The Segal Institute for Clinical Research recruitment team is looking for quality people, because our continued success has lead to our growth. Please fill out the form below and copy and paste your resume. Someone will be in touch with you shortly.

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OPEN POSITIONS

Reports to: Rater Supervisor and Director of Community Outreach
Department: Medical, Clinical, Recruitment

Summary:

The Screening Specialist is responsible for administering various psychometric efficacy scales, as well as completing interviews/ratings on study participants specific to several study protocols. This person will perform interview/ratings on study subjects to determine current levels of functioning and to create a clinical impression of the study subject’s current presentation throughout the duration of the trials. Clinical interviewing skills are a must, as well as knowledge of DSM IV and 5 diagnoses.

DUTIES & ESSENTIAL JOB FUNCTIONS

  • Gather information from prospective subjects through a prescreening interview and determine eligibility for research trials.
  • Conduct telephone and in-person prescreen interviews of potential research volunteers.
  • Obtain detailed medical and psychiatric histories of potential volunteers.
  • Evaluate potential eligibility of interested volunteers and forward eligible candidates to the appropriate research sites or to the Rater Supervisor for final assessment.
  • Maintain knowledge of enrolling and upcoming study protocols at all research sites for proper referrals.
  • Build and maintain database of potential volunteers for future trials, including current participation status.
  • Assist in maintaining site specified levels of recruitment.
  • Follow Sponsor, or protocol, specific requirements and applicable SICR internal SOPs.
  • Review all medical records.
  • Manage subject crises with professionalism and clinical expertise.
  • Perform other related duties incidental to the work described therein.

Skills:

  • Ability to deliver information to caller/patient inquiries
  • Professional verbal and written communication skills
  • Ability to project a professional image through telephone interaction.
  • Strong interpersonal and communication skills
  • Ability to type 30 wpm
  • Excellent computer knowledge.
  • Flexibility, proactive and perseverance.
  • Able to work well under pressure.
  • Able to handle multiple projects simultaneously.
  • Bilingual English/Spanish is a must.

Education:
Bachelor’s Degree or higher in a Psychology related area

Experience:

Superior patient interview and diagnostic skills
Bilingual English/Spanish

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

APPLY

 

Reports to: Clinical Research Coordinator
Department: Medical & Clinical

DUTIES & ESSENTIAL JOB FUNCTIONS:

Data Entry

  • All data will be entered and data queries will be addressed according to sponsor/CRO timeline requirements.
  • Review and monitor patient/subject clinical and research laboratory trial data for completeness, accuracy, and consistency identifying and resolving data discrepancies.
  • Update/correct/review data in the clinical databases based on resolved data queries.
  • Abstract information and accurately enter it into protocol specific data capture system.
  • Perform routine audits to insure quality and completeness of the data submitted.
  • Serve as a liaison and reference resource to Investigators, coordinators and other staff members with questions about data collection or protocol procedures and requirements.
  • Maintain ongoing contact with data suppliers (study team) to insure timely and complete delivery of data.
  • Participate in meetings with regard to data quality assurance.
  • Assist in the development of data acquisition forms (source documents).
  • Provide input to support policies and goals of the department.
  • Observe the requirements of working with confidential data
  • Perform other duties as assigned.

Administrative Duties

  • Posting and updating Clinical Conductor database.
  • Review and monitor daily visit log(s) for completeness, accuracy, and consistency while identifying and resolving discrepancies.

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

APPLY

 

Reports to: Clinical Operations/Rater Supervisor
Department: Medical & Clinical

Summary:

The Clinical Research Assistant completes activities to ensure protocol, regulatory and Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) compliance. Assist the research coordinator in developing solutions to complex problems that impact the timely and accurate conduct of clinical research.

DUTIES & ESSENTIAL JOB FUNCTIONS:

  • Help determine staff, facility, and equipment availability
  • Assess study population/availability
  • Liaison with health-care professional/providers to determine best recruitment practices for study as needed
  • Schedule and/or coordinate pre-study site visits with Sponsor/CROs as instructed
  • Identify potential subjects from review of existing protected health information based on inclusion/exclusion criteria
  • Recruit subjects according to IRB/protocol approved methodologies; consent subjects including discussion of treatment and intervention alternatives and ensure that Informed Consent forms are properly signed before the start of the study
  • Prepare and organize space for study related equipment and supplies
  • Perform subject interviews and assessments at study visits for data required by protocol Assess and ensure subject safety throughout participation in trial
  • Conduct study-related non-medical/behavioral assessments/interventions; Conduct study procedures/interventions (appropriate licensure may apply)
  • Determine appointments per protocol; Schedule subjects for appointments
  • Contact outside health-care providers to obtain follow-up information; Communicate with subjects to obtain follow-up information
  • Monitor study team compliance with required study procedures and GCP standards
  • Extract data from source documents; Complete Case Report Forms (CRFs) or database entries; Audit for accuracy and correct CRFs; Resolve sponsor queries; Provide/create source documentation tools for subjects’ charts/records
  • Record and document protocol deviations; Communicate with PI and Sub-Investigators about changes in the trial
  • Order and receive drug/device supplies; Dispense drug/device supplies (calculate dosage as needed) as directed by the CRC; Maintain files of drug/device dispensation, compliance and return
  • Ensure proper collection, processing, shipment of specimens, and documentation; Communicate with laboratory, Principal Investigator, and sponsor regarding laboratory findings
  • Compose and submit continuing review/amendments/close-out information to the IRB; Schedule and prepare for monitor visits; Prepare and respond to sponsor or FDA audits
  • Archive documents for study per sponsor/government/institutional requirements once authorized
  • Develop and implement teaching tools for subjects and families; Serve as an advocate for the subjects and their family
  • Maintain current knowledge of regulatory affairs and/or issues
  • Attend recruitment meetings when instructed
  • Perform other related duties incidental to the work described herein and as delegated by the CRC
  • When necessary remain on call to assist patients with their concerns, keep and complete the On Call Log.

Accounts Receivable:

  • Completing NPFs within 24 hours of consenting a new patient.
  • Completing CTNs within 24 hours of an admission.
  • Completing visit logs at the end of each day including utilization of each grey cell.
  • Verifying patients before consenting.
  • Reviewing the monthly ICF and Randomization Report for referral accuracy.
  • Reporting Hospital Census data.
  • Completing SICR Additional Procedure/Additional Hospitalization forms.
  • Reporting changes to the Weekly Performance Report by Friday of each week.

Regulatory:

  • Obtaining signature from PI – IRB forms, FDF, protocol signature page, IB receipt (if applicable).
  • Obtaining signature from Sub-Investigators (doctors).
  • Obtaining signature from administrator for IRB waiver.
  • Obtaining signature from administrator for hospital manual.
  • Obtaining PI signature when we receive amended protocol and IB receipt (if applicable).
  • Upon receipt review data on CDs (after study closure) and return to regulatory.
  • Obtain PI signature on IND safety reports and send to regulatory for new studies (see attached e-mail).

Advertising and Marketing:

  • Creating a study guide before a new study begins.
  • E-mailing a study guide to all users before a study begins.
  • E-mailing enrollment opening or closing before a study begins and when a study closes.
  • Updating the ASR on the 1st and 15th of every month.
  • Communicating advertising needs.
  • Communicating the need for study or company flyers.

Administration:

  • Supplying check requests by Thursdays for the following week’s visits.
  • CSubmitting accurate hospital census information at the end of each business day.
  • Completing registrations for investigator meetings prior to the meeting.
  • Completing petty cash request form, with all receipts.
  • Maintaining a list of all supplies required by the site (i.e. cigarettes, patient candy…).
  • Completing time sheets and emailing it to administration (must be signed by manager).
  • Returning all patient checks that need to be voided (if the patient has not picked it up and 90 days have passed).
  • Requesting approval for office supply orders exceeding $100.

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

APPLY

 

Reports to: Site Leader/Physician Investigator
Department: Medical & Clinical

Summary:

The Clinical Research Coordinator initiates, conducts, completes and reports clinical studies/trials. Completes and maintains regulatory documents for clinical studies/trials to ensure protocol, regulatory to ensure protocol, regulatory and Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) compliance. Develop solutions to complex problems that impact the timely and accurate conduct of clinical research. The position requires strong written communication skills, attention to detail, ability to meet multiple and changing deadlines, the ability to interact with a variety of people and to consult numerous sources for information in order to prepare documents and assist with responses to IRB and sponsor questions that are compatible with numerous policies and procedures. Incumbent must be able to work in a very busy interactive environment with frequent interruptions and to perform tasks accurately and quickly.

DUTIES & ESSENTIAL JOB FUNCTIONS:

  • Participate in protocol reviews; evaluate the protocols, study designs and risk to subject population.
  • Help determine staff, facility, and equipment availability; assess study population/availability.
  • Liaison with health-care professional/providers to determine best recruitment practices for study.
  • Participate in preparation and negotiation of study budget.
  • Review, critically evaluate and comment on study contracts/agreements.
  • Schedule and/or coordinate pre-study site visits with Sponsor/CROs.
  • Schedule study-related meetings and training sessions; provide instruction to study team for specific study assignments; educate staff regarding scientific aspects of study; train ancillary staff regarding clinical staff.
  • Identify and schedule screening procedures and review results; monitor enrollment goals and modify recruitment strategy as needed.
  • Identify potential subjects from review of existing protected health information based on inclusion/exclusion criteria.
  • Recruit subjects according to IRB/protocol approved methodologies; consent subjects including discussion of treatment and intervention alternatives and ensure that Informed Consent forms are properly signed before the start of the study.
  • Prepare and organize space for study related equipment and supplies.
  • Perform subject interviews and assessments at study visits for data required by protocol.
  • Assess and ensure subject safety throughout participation in trial.
  • Conduct study-related non-medical/behavioral assessments/interventions; Conduct study procedures/interventions (appropriate licensure may apply).
  • Determine appointments per protocol; Schedule subjects for appointments.
  • Contact outside health-care providers to obtain follow-up information; Communicate with subjects to obtain follow-up information.
  • Monitor study team compliance with required study procedures and GCP standards.
  • Extract data from source documents; Complete Case Report Forms (CRFs) or database entries; Audit for accuracy and correct CRFs; Resolve sponsor queries; Provide/create source documentation tools for subjects’ charts/records.
  • Record and document protocol deviations; Communicate with PI and Sub-Investigators about changes in the trial.
  • Order and receive drug/device supplies; Dispense drug/device supplies (calculate dosage as needed) as directed by the CRC; Maintain files of drug/device dispensation, compliance and return.
  • Ensure proper collection, processing, shipment of specimens, and documentation; Communicate with laboratory, Principal Investigator, and sponsor regarding laboratory findings.
  • Compose and submit continuing review/amendments/close-out information to the IRB; Schedule and prepare for monitor visits; Prepare and respond to sponsor or FDA audits.
  • Audit documents and pertinent files and prepare for storage; Archive documents for study per sponsor/government/institutional requirements.
  • valuate team effort at site; Document “drop outs” (e.g. causes, contact efforts).
    Develop and implement knowledge of regulatory affairs and/or issues; maintain a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings.
  • Develop and implement teaching tools for subjects and families; serve as an advocate for the subjects and their families.
  • Attend recruitment meetings when instructed.
  • Perform other related duties incidental to the work described herein.
  • Be familiar with HIPAA regulations.

Accounts Receivable:

  • Completing NPFs within 24 hours of consenting a new patient.
  • Completing CTNs within 24 hours of an admission.
  • Completing visit logs at the end of each day including utilization of each grey cell.
  • Verifying patients before consenting.
  • Reviewing the monthly ICF and Randomization Report for referral accuracy.
  • Reporting Hospital Census data.
  • Completing SICR Additional Procedure/Additional Hospitalization forms.
  • Reporting changes to the Weekly Performance Report by Friday of each week.

Regulatory:

  • Obtaining signature from PI – IRB forms, FDF, protocol signature page, IB receipt (if applicable).
  • Obtaining signature from Sub-Investigators (doctors).
  • Obtaining signature from administrator for IRB waiver.
  • Obtaining signature from administrator for hospital manual.
  • Obtaining PI signature when we receive amended protocol and IB receipt (if applicable).
  • Upon receipt review data on CDs (after study closure) and return to regulatory.
  • Obtain PI signature on IND safety reports and send to regulatory for new studies (see attached e-mail).

Advertising and Marketing:

  • E-mailing enrollment opening or closing before a study begins and when a study closes.
  • Updating the ASR on the 1st and 15th of every month.
  • Communicating advertising needs.
  • Communicating the need for study or company flyers.

Administration:

  • Supplying check requests by Thursdays for the following week’s visits.
  • CSubmitting accurate hospital census information at the end of each business day.
  • Completing registrations for investigator meetings prior to the meeting.
  • Completing petty cash request form, with all receipts.
  • Maintaining a list of all supplies required by the site (i.e. cigarettes, patient candy…).
  • Completing time sheets and emailing it to administration (must be signed by manager).
  • Returning all patient checks that need to be voided (if the patient has not picked it up and 90 days have passed).

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

APPLY

 

Reports to: Director of Community Outreach
Department: Community Outreach

Summary:

The Outreach Coordinator is an experienced professional responsible for new business development and patient recruitment. They are responsible for increasing clinical trial enrollment and cultivating strategic partnerships through community outreach activities. This position also develops sponsorship/business arrangements and relationships with businesses, individuals, schools, and other organizations interested in supporting Segal Institute for Clinical Research program areas.

Summary of Essential Job Functions:

  • Recruit and enroll patientes into currently enrolling clinical research trials.
  • Recruit patients for upcoming study waitlists.
  • Responsible for the Mobile Prescreens recruitment efforts in accordance with program standards and goals.
  • Responsible for planning, developing, implementing and evaluating programs to attract volunteers.
  • Works with SICR’s Marketing department to develop advertising and promotional materials for the Mobile screening van and compiles statistics on recruitment efforts.
  • Assists supervisor to meet recruitment goals and work independently to meet those goals.
  • Meet established goals, pertaining to subject enrollment, enrollment rates and enrollment deadlines.
  • Work closely with all sites to understand and overcome enrollment challenges.
  • Coordinate recruitment initiatives to increase clinical trial enrollment. This includes delivering presentations designed to promote the organization and its services to the community.
  • Leverage previously established relationships and forge new relationships, in the community, to promote clinical research and increase trial enrollment.
  • Schedule regular meetings with community organizations to create new referral opportunities, educate the organizations about any new enrolling studies, and learn about new partnership opportunities or upcoming events.
  • Search and implement new ways to engage the community, such as speaking engagements and health fairs, with the goal of increasing clinical trial enrollment.
  • Assist the Community Outreach Director with creating and implementing recruitment plans and implement them for all enrolling and upcoming studies.
  • Report on program activities, including entering accurate data in a timely way into the necessary data systems.
  • Maintain a database of community resources and partnerships for regular communications and marketing purposes, including the distribution of the monthly e-newsletter.
  • Maintain a log of enrollment metrics, including patients who screened, enrolled and completed trials, based on your recruitment efforts.
  • Prepare and maintain internal reports and coordinate internal meetings to review results and develop new strategies.
  • Work seamlessly with the call center when sending referrals and scheduling appointments.
  • Be current on all enrolling studies, upcoming studies, and contract goals and enrollment metrics at each site.
  • Be current on all advertising campaigns and initiatives at each site.
  • Be familiar with HIPAA regulations.

Experience/Training:

  • Marketing experience is highly desirable.
  • Must have a proven track-record in successful community outreach/recruitment/sales.

Education:
Bachelor’s Degree is required.

Skills, Knowledge, and Abilities:

Must have currently established working relationships in the community, preferably with mental health, addiction, and women’s health organizations.
Must be bilingual in English and Spanish.
Must be able to work in a fast-paced environment, meet goals, and be flexible to changing priorities.
Demonstrates excellence in both oral and written communications, especially with public speaking and presentations skills.
Must be a strategic thinker, analytical, and performance driven.
Must have a strong ability to connect with others and forge strong relationships.
Committed to the mission of clinical research.
Highly organized and IT-competent – proficient in Microsoft Office programs.
Ability to multi-task and manage time.
Moderate physical demands.
Must be available to work weekends and evenings, when needed.
Must have reliable transportation.

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

APPLY

 

Reports to: Inpatient Manager
Department: Medical & Clinical

Summary:

The Phlebotomist will be the one who draws blood from patients, collects a variety of other specimen samples as well as label the blood vials that you have filled. You will also be responsible for bringing all blood and specimen samples to the laboratory either in the hospital you are working in or locally in the area.

Summary of Essential Job Functions:

  • Verifies patient identification
  • Collect blood samples from patients by performing venipunctures and/or fingersticks
  • Label vials with patient names and dates
  • Practice proper patient identification, especially when working on hospital floors
  • Tracks collected samples by initialing, dating, and noting times of collection
  • Maintain daily tallies of sample collections performed
  • Decipher the best method for drawing blood depending on the specific patient
  • Transport all specimen samples to a nearby laboratory
  • Centrifuge blood samples, depending on if this is allowed in the state you are working in
  • Expect to work with a large number of patients varying in age and health status
  • Be friendly, courteous and sympathetic when it comes to working with patients
  • Keep phlebotomy cart or station well-organized at all times
  • Practice infection control standards at all times when working with patients and equipment
  • Vital assessment
  • Electrocardiogram Procedures
  • Filing laboratory Documents
  • Urine Drug Screens procedures
  • Urine Pregnancy Test procedures
  • Laboratory shipment including Dry Ice

Skills And Qualifications:

  • Able to analyze information
  • Attention to detail
  • Knowledge of good laboratory practices
  • Quality control
  • Good communications skills
  • Great customer service skills
  • Team player attitude
  • Ability to remain focus under stressful situations

Education:

  • Associates degree in science or health-related field
  • Phlebotomist Certification

Experience:

At least one year of practical experience

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

APPLY

 

Reports to: Regulatory Manager, Director of Quality Assurance and Vice President
Department: Regulatory

Summary:

The Regulatory Specialist completes and maintains regulatory documents for clinical studies/trials to ensure protocol, regulatory and Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) compliance. Assists Regulatory Manager and trains regulatory staff as delegated by the Regulatory Manager or Director of Quality Assurance. The position requires strong written communication skills, attention to detail, ability to meet multiple and changing deadlines, the ability to interact with a variety of people and to consult numerous sources for information in order to prepare documents and assist with responses to IRB and sponsor questions that are compatible with numerous policies and procedures. Incumbent must be able to work in a very busy interactive environment with frequent interruptions and to perform tasks accurately and quickly.

Summary of Essential Job Functions:

  • Notify administration, regulatory, recruitment, and study team including PI upon receipt and submission of regulatory documents
  • Request list of staff to be included as sub-investigators on 1572 from study coordinator
  • Request answers to questions from CRO/Sponsor (see attachment) prior to completion of documents
  • Prepare and submit regulatory documents to CRO/IRB
  • Obtain study advertising materials from other studies with same indication and submit to advertising director for approval prior to submission of initial regulatory document
    • save ads (submission and IRB approval) under the study
    • complete “Recruitment Tracking Log” for ads
  • Obtain subject stipend/compensation from contract department
  • Review initial IRB approved consent form to ensure accurate information such as site address (if applicable), office and emergency phone numbers, and compensation
  • Review all tabs in the regulatory binder and make copy of documents for study coordinators as applicable to their study
  • Create hospital/facility manual for study and provide administrator with the manual at satellite site
  • Create study contact sheet for each study and complete section as applicable
  • Create and maintain a consent log under each study
  • Ensure regulatory binders are logged out and signed in according to SICR SOPs
  • Follow procedures pertaining to each study as applicable to department
  • Maintain regulatory binders for each study
  • Create “Correspondence Binder” as part of regulatory binders for each study
  • Update binders throughout the duration of study until study close-out
  • Follow other SICR SOPs as pertaining to regulatory affairs
  • Work closely with clinical research coordinator to ensure issues are resolved after monitor’s visit
  • Provide copy of protocol amendment and revised investigator drug brochure (IDB) after IRB approval
    • notify site by e-mail when amendment is received and file under study
    • notify site by e-mail when amendment is IRB approved and attach copy of approved documents along with amendment
    • notify site to train team on amendment and provide regulatory department with copy of training document for filing
    • after receipt of IRB approved amendment, informed consent form, if applicable, and request in-patient sites to provide copy to hospital administrator for their manual
  • Ensure documents are filed in binders before monitor’s visits
  • Maintain current knowledge of regulatory affairs and/or issues
  • Attend Study Initiation Visit (SIV) and Close Out Visit (COV)
  • Archive documents for study per SICR SOPs
  • Create and maintain SICR staff CVs.
  • Perform other related duties incidental to the work described herein and as delegated by the Regulatory Manager or Director of Quality Assurance.
  • May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.
  • Reports, monitors, distribute and maintain files for all safety information including Investigational Drug Brochures, IND safety reports and Serious Adverse Events (SAE) reports.
  • Prepares regulatory documentation packets and creates all FDA 1572 Forms for initial submissions. Ensures all necessary forms are submitted to Sponsor Company to activate protocols.
  • Tracks expirations and retrieves current documentation for medical licensures, CVs and laboratory accreditations.
  • Posts regulatory documents including protocols, amendments, consent forms, SAE forms etc. on the company server.
  • Strong focus on teamwork, attention to detail, excellent organizational and planning skills. Must have ability to prioritize, excellent communication skills, and ability to work in a multi-task environment.
  • Proficient with Microsoft Word, Excel. Training in GCP and HIPAA regulations will be required.
  • May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.
  • Ability to verbally communicate effectively with contract research associates (CRAs) or study monitors, company’s coordinators, marketing staff and management; pharmaceutical companies; contract research organizations (CROs), Institutional Review Board (IRBs); and other team members.

Experience/Training:

  • Must have clinical research experience working with protocols including human subjects’ applications and informed consent documents.
  • Must be able to maintain confidentiality.
  • Demonstrated organizational skills including ability to develop accurate filing systems.
  • Familiarity with medical terminology.
  • Experience with computer systems and software (including databases, spreadsheets, and word processing). Ability to use software to develop organized information sources and to provide a variety of reports.
  • Experience with Microsoft Office products such as: Word, Adobe and Excel.

Education:
Minimum, Bachelor’s Degree

Specifications:

Minimum 2-3 years’ experience in clinical research regulatory required.
Read, Write and Speak English fluently
Strong written communication skills
Ability to respond appropriately to Sponsor/CRO representative
Interaction with a wide variety of people
Maintain confidential information
Ability to communicate only the facts to recipients or to decline to reveal information
Ability to project a professional, friendly, helpful demeanor
Must be able to remain in a stationary position 90% of the time
Constantly operates a computer and other office productivity machinery, such as a copy machine, fax
machine, printer, and paper shredder.
The person in this position frequently communicates with research staff, Principal investigators,
marketing department, and sponsor company representatives regarding regulatory documents. This
individual must be able to exchange accurate information in these situations.
Frequently moves boxes weighing up to 20 pounds for archiving or review by a sponsor company
representative and/or regulatory agency. Boxes can be transported by hand truck.

Nothing in this position description restricts management’s rights to assign or reassign duties and responsibilities to this position at any time.

APPLY