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OPEN POSITIONS

Reports to: Rater Supervisor and Clinical Operations
Department: Medical and Clinical

Summary:

The Clinical Rater 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.

Summary of Essential Job Functions:

  • Administer clinical efficacy scales on subjects with various diagnoses such as ADHD, Alzheimer’s Disease, Bipolar Disorder, Major Depressive Disorder, Substance Use Disorders and Schizophrenia.
  • Perform diagnostic evaluations.
  • Gather information from prospective subjects through a prescreening interview and determine eligibility for research trials.
  • Submit accurate data utilizing Good Clinical Practices (GCP) and identified scoring conventions.
  • Work with SICR Principal Investigators and coordinators in initiating assessments, and assist them with data query completion and data clarification.
  • Assist in maintaining site specified levels of recruitment.
  • Interact with Sponsors, Study Monitors and Medical Monitors from pharmaceutical companies in a professional manner.
  • Follow Sponsor, or protocol, specific requirements and applicable SICR internal SOPs.
  • Utilize technology required to conduct remote assessments.
  • Review all medical records.
  • Manage subject crises with professionalism and clinical expertise.
  • Attend all required investigator meetings and internal SICR meetings; expected travel is 10-15%.
  • Successfully complete all sponsor-assigned training through web-portals and meetings to obtain rater certification on specified scales.
  • Participate in monthly rater meetings, ongoing rater calibration and training.
  • Perform other related duties incidental to the work described therein.

Skills And Qualifications:

  • Superior patient interview and diagnostic skills
  • Clinical assessment experience preferred
  • Bilingual English/Spanish is preferred

Education:

  • Master’s Degree or higher in a Psychology related area

Experience:

At least 1 year of experience in a call center or related field.

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

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Reports to: Chief Scientific Officer/ Medical Director
Department: Medical & Clinical

Summary:

The Principal or Sub Investigator is responsible for the oversight and execution of Psychiatric clinical trials testing new medications on the behalf of the sponsor/pharmaceutical companies. The investigator promotes Good Clinical Practices (GCP) in the conduct of Clinical Investigations by ensuring the integrity of data generated at the site and directing the conduct of the clinical investigation as to the guidelines issued by State and Federal Authorities and the Sponsor. The Investigator works collaboratively with the study team and regulatory personnel to ensure welfare of study participants.

Summary of Essential Job Functions:

  • Responsible for maintaining up-to-date curriculum vitae.
  • Provide Sponsor and IRB with documentation of credentials as required.
  • Maintain all required licenses to practice and execute the job as PI or Sub-I.
  • Assume responsibility as the Principal or Sub-Investigator for the duration of clinical trials.
  • Demonstrate the proper education, training and experience to conduct the clinical investigation.
  • Disclose conflicts of interest as described in the regulations.
  • Perform psychiatric evaluations.
  • Evaluate and screen potential subjects based on study eligibility criteria.
  • Perform and review psychiatric ratings performed by raters in accordance with the clinical study protocol.
  • Complete protocol specific training as required per sponsor’s vendors to obtain certification to conduct testing and rating scales for specific protocols.
  • Complete all documentation, paper and electronic, as required per protocol.
  • Provide oversight and ensures proper delegation of duties to appropriate staff.
  • Provide and maintain updated study related documentation as required by the clinical research trial to ensure data integrity.
  • Evaluate and report safety reports, protocol noncompliance and any other protocol specific reports.
  • Follow requirements for FDA form 1572.
  • Collaborate with operational and management team to ensure site goals are met.
  • Attend Investigator Meetings and educational seminars.
  • Travel to Investigators meetings as needed.
  • Provide on call outpatient and/or inpatient coverage to subjects enrolled in clinical studies.

Skills And Qualifications:

  • Ability to read, write, and interpret the English language (Bilingual/spanish preferred)
  • Possess a valid M.D. or D.O. degree
  • Board Certification in psychiatry or in process of obtaining one.
  • Active DEA license, or able to obtain one
  • Active license to practice medicine in the state of Florida, or ability to obtain one immediately
  • Strong interpersonal and leadership skills, self-motivation, and high personal integrity and ethics required

Education:

  • Possess a valid MD or DO medical degree
  • Board certification in psychiatry

Experience:

1-3 years experience conducting psychiatric clinical research trials as either a PI or Sub-investigator, or other relevant 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: Site Lead & Site Manager
Department: Clinical

Summary:

The Clinical Research Coordinator is responsible for managing clinical trial performance and ensuring the conduct of their clinical trials is congruent with the vision and mission of the company. The CRC plans, coordinates, evaluates, and manages the care of both the participants and the data for their assigned trials. The CRC follows study specific protocol guideline and communicates and interacts with Investigators, clinic staff, CROs and Sponsors to effectively perform clinical research and coordinate research activities. All duties carried out by the CRC are done so in accordance with company policies, SOPs, and Good Clinical Practice (GCP) as well as all applicable local, state and federal regulations.

Primary Responsibilities:

  • Coordinate clinical trials conducted by a supervising Principal Investigator in accordance with FDA, GCP and protocol guidelines.
  • Identify potential problems or inconsistencies and take action as appropriate.
  • Articulate protocol issues to CRO and/or Sponsor, Site Lead, Manager, Principal or Sub-Investigator, and other members of the study team.
  • Collect initial subject health and demographic information by interviewing subjects and accessing other appropriate sources.
  • Review subject comprehensive medical documentation to determine protocol eligibility under the supervision of the Principal Investigator.
  • Ensure a flow of communication including telephone conferences between subject, study staff, referral sources and recruitment team, Sponsor and/or CRO, Monitor(s) and Auditors, if applicable.
  • Perform clinical tasks including, but not limited to: vital signs, height and weight, ECG, phlebotomy, specimen processing and packaging.
  • Maintain timely internal source documentation as well as sponsor-required information.
  • Maintain timely EDC data entry and query resolution.
  • Maintain timely CTMS data entry of patient visits and study information.
  • Complete Verification of subjects before consenting.
  • Report hospital census data, if applicable.
  • Dispense and maintain accurate records of investigational and study product.
  • Educate subject and family members regarding specific studies and clinical drug trials in general.
  • Complete all monitor and sponsor queries in a timely manner.
  • Perform Quality Control (QC) checks on all trials per company SOP and interface with QA Director as needed.

Recruitment Responsibilities:

  • Send “All Users” email upon enrollment activation or enrollment closure
  • Participate in recruitment planning meetings prior to study start
  • Provide weekly updates to Active Studies Report
  • Communicate all advertising needs to recruitment team
  • Maintain weekly communication with recruitment team in order to maximize recruitment in all enrolling trials
  • Communicate the need for study or company flyers

Secondary Responsibilities:

Maintains Quality Service and Departmental Standards by

  • Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
  • Assisting in establishing and enforcing departmental standards

Contributes to team effort by

  • Working with internal staff to resolve issues
  • Exploring new opportunities to add value to the organization and departmental processes
  • Helping others at the site to achieve site goals
  • Performing other duties as assigned
  • Support the organization’s mission and goals

Maintains Technical and Industry Knowledge by

  • Attending and participating in applicable company-sponsored training
  • Attending and participating in Sponsor investigator meetings, recruitment meetings, and trainings

Skills And Qualifications:

  • CCRC or CCRP certification preferred
  • Strong motivational skills and abilities – promoting a team-based approach
  • Strong interpersonal and communication skills, both verbal and written
  • Strong organizational and leadership skills
  • Goal oriented
  • Ability to maintain a professional and positive attitude
  • Detail Oriented
  • Strong critical thinking skills
  • Strong ability to multi-task
  • Strong computer skills
  • Ability to support and demonstrate the mission and goals of the company
  • Excellent interpersonal and customer service skills
  • Knowledge of medical terminology and clinical practices

Experience:

At least 2 years of experience as a CRC in clinical research or relevant clinical role

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 Coordinator 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 in cidental 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

Reports to: Marketing Manager
Department: Administration

Summary:

Segal Institute for Clinical Research is a consortium of research sites specializing in psychiatric, neurological, addiction, medical and women’s health clinical trials. A 60-plus staff of full-time Principal Investigators, Subinvestigators, Coordinators, Research Assistants and Master’s-and Doctorate-level Raters conducts clinical trials in outpatient, inpatient, nursing homes, and sleep laboratories. Segal Institute is currently conducting Phase I-IV research trials in 7 different sites in South Florida and South Carolina. Integral to Segal Institute’s success is its centralized operations consisting of quality assurance and improvement managers, rater calibration specialists, recruiters, advertising coordinators, contract managers and call-center.

ESSENTIAL JOB FUNCTIONS

  • Provide bedside care
  • Administer medications and document therapeutic effects
  • Take vital signs (temperature, blood pressure, pulse and respiration)
  • Assist with resident comfort
  • Perform other tasks as assigned

REQUIREMENTS

  • Active Florida LPN license
  • Current CPR
  • Experience with psychiatric patients and chemically dependent patients preferred
  • Must have a clear background screening
  • The ability to read and communicate in English both verbally and in writing
  • Working knowledge of Nurse Practice Acts
  • Valid Driver’s License

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 Clinical Operations
Department: Clinical Operations

Summary:

The Quality Control Associate collaborates with management and staff to develop, verify and implement procedures, in accordance with Good Clinical Practice (GCP) and federal regulations, that support Segal Trials in accomplishing its quality management goals. Under the supervision of the Director of Clinical Operations, the individual in this role reviews patient and study data to verify research protocol compliance and adherence to protocol, as well as data integrity, and data control principles. The scope of the Quality Control Associate extends to all study-related data collection, including Clinical Trial Management Systems (CTMS), Regulatory documentation, Source documentation, Electronic Data Capture, and other systems, as appropriate.

Summary of Essential Job Functions:

  • Perform study subject reviews, ensuring protocol compliance as well as compliance with site SOPs and all other applicable regulations. Such reviews will include, but not be limited to, the following:
    • Informed Consent Forms (ICFs)
    • Subject study eligibility
    • Adverse events (AEs)
    • Concomitant medication
    • Investigational Product (IP) accountability
    • Investigational Product storage
    • Progress Notes
    • Medical history
    • Medical records
    • Hospital records (when applicable)
    • Lab values and documentation
    • Other diagnostic tests
    • Ratings scales
    • Other Visit procedures and examinations
    • Progress Notes
    • Investigator Notes
    • Regulatory documents
    • Other collected and documented data, as appropriate
  • Confirm site compliance measures and documentation including, but not limited to, the following:
    • Equipment calibration
    • Temperature logs
  • Perform data comparisons between Electronic Data Capturing (EDC) systems and Source Documents to ensure all data is initially gathered in Source Documents, and data is correctly transcribed into EDC.
  • Perform data comparisons between data collected during a specific clinical trial and the related protocol to ensure that generated during the study adheres to protocol requirements
  • Verify the integrity of all clinical trial data in accordance with ALCOA-C principles (accurate, legible, contemporaneous, original, accurate and complete).
  • Utilize a dedicated QC checklist for study, subject and site compliance reviews.
  • Maintain thorough documentation to confirm resolution of any issues of concern.
  • Provide regular reports to the Director of Clinical Operations and Management Teams to advise leadership of quality issues and to guide enterprise process corrections & improvements.
  • Work cooperatively with clinical site staff, investigators, regulatory staff, and other Segal Trials’ employee groups to effectively communicate quality concerns, to train or retrain staff as needed, and to guide improved quality and compliance measures throughout the enterprise.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Report to duty at physical locations other than the primary assigned location(s) on an as-needed basis. The fluctuating nature of the industry and the existence of multiple physical business addresses mean that employees must be prepared to adjust work location within reason as dictated by business needs.

Skills And Qualifications:

  • Possesses exceptional attention to detail.
  • Able to work independently with little feedback or direction.
  • Functions well under high-pressure conditions.
  • Possesses highly effective communication skills
    • Exhibits highly effective verbal and written communication skills through positive interactions with coworkers, managers, clients and vendors
  • Models team collaboration skills.
    • Works effectively and collaboratively with team members to accomplish goals.
  • Independently displays a passion to learn and innovate and maintains knowledge of industry development through personal readings and individual trainings.
  • Balances tasks with competing priorities effectively without direction from supervisor.
  • Solicits & responds positively to direction & constructive criticism from supervisors, managers, & peers.

Requirements:

  • 2+ years of relevant work experience in clinical research.
  • Bachelor’s degree in Science or Business required
  • Proficiency in English required.
  • Proficiency in English and Spanish preferred
  • Proficiency with Microsoft Office, including Outlook and Excel

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

APPLY