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OPEN POSITIONS



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.

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Reports to: Chief Scientific Officer Dept: Medical and Clinical

Summary:

As a Psychiatrist/Investigator, you will be responsible for the conduct of the clinical trials. In this unique position you will work very closely with various medical and regulatory Sponsor personnel to ensure the health and welfare of study participants.

Summary of Essential Job Functions:

  • Responsible for protecting the rights, safety and welfare of study participants.
  • Responsible for ensuring that the clinical trial is conducted according to the investigational plan and all applicable regulations
  • Review and evaluate protocols and provide clinical and scientific support.
  • Interact with regulatory bodies as relevant to clinical operations.
  • Attend clinical study initiation and investigators meetings.
  • Determine that inclusion/exclusion criteria are applicable to the study population.
  • Perform psychiatric evaluations, physical examinations, review lab data, ECGs and other medical information to ensure volunteers are medically and mentally fit upon entering the study.
  • Perform on-study and post-study physical examinations to monitor the physical and mental well being of volunteers throughout the study.
  • Complete Abnormal Involuntary Movement Scale (AIMS) and other movement scales as needed on subjects in the clinical study.
  • Evaluates all available clinical data (including laboratory and ECG reports) in accordance with the study protocol.
  • Performs clinical pre-screening of potential volunteers to identify for a suitable clinical study.
  • Provides vacation coverage as assigned.

Competencies

  • Communication Proficiency.
  • Decision Making.
  • Ethical Conduct.
  • Personal Effectiveness/Credibility.
  • Problem Solving/Analysis.
  • Thoroughness.

Travel

The position requires some travel between outpatient and inpatient sites and to attend national Investigators Meetings.

Education and Experience:

  • Medical degree.
  • One to Three years of professional experience.

Additional Eligibility Qualifications:

  • M.D. or D.O. degree.
  • Board Eligible or Board Certified Psychiatrist.
  • Bilingual preferred (English/Spanish)
  • Must have and maintain a current Controlled Substances Registration Certificate from the U.S. Drug Enforcement Administration.
  • Must have and maintain a current Physician License and Controlled Substance License from the State.
  • Must have and maintain a valid driver’s license, maintain automobile insurance coverage and have access to an automobile.
  • Clinical research experience preferred.

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

APPLY