Clinical Data Coordinator(4)
The Clinical Research Data Coordinator maintains essential study documents for clinical research studies and enters data onto Case Report Forms and ensures study compliance.
Essential Generic Job Functions (List in order of importance):
1. Obtains patient consent for minimal risk studies.
2. Organizes and prepares for all study related sponsor visits up including, but not limited to Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, Internal Audits, and Sponsor Audits.
3. Verifies that all patients have provided informed consent prior to entering study specific data.
4. Compares schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs.
5. Records accurate data by completing paper or electronic CRFs.
6. Resolves data queries accurately and within study specific timeframes.
7. Maintain adequate inventory of research supplies necessary for research activities. Ensures supplies and kits are current and safely disposes of expired/closed supplies.
8. Centrifuges human specimens per study specific laboratory manual guidelines.
9. Processes and ships human specimens and biologic agents per protocol guidelines and Federal Regulations.
10. Obtains and copies research related Curricula Vitae for Investigators as found on FDA form 1572, Medical Licenses for Investigators as found on FDA form 1572, Lab Certifications and Lab Normals for labs as found on FDA form 1572, Financial Disclosures for Investigators as found on FDA form 1572 and files such documents in the corresponding study specific regulatory binders.
11. Ensures regulatory binders are maintained with essential study documents.
12. Maintains timely patient follow-up by accurately reviewing the study specific follow-up schedule in the protocol and completes follow-up CRFs.
13. Reports, tracks, and files off-site Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB) within the required time frame dictated by the IRB of record.
14. Utilizes the SAE reporting log to track the receipt, submission and acknowledgement of off-site SAEs per protocol.
15. Prepare reports, including but not limited enrollment logs which assists with institutional statistical analysis.
16. Lifts a minimum of 5 lbs., pushes and pulls a minimum of 10 lbs. and stands a minimum of 4 hours a day.
17. Ability to sit and concentrate at a computer workstation for a minimum of 4 hours at a single sitting.
18. Identifies the needs of the patient population served and modifies and delivers care that is specific to those needs (i.e., age, culture, language, hearing and/or visually impaired, etc.). This process includes communicating with the patient, parent, and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.).
19. Adheres to the standards identified in the Medical Center's Organizational Competencies.
Essential Position Specific Functions:
- Prepares reports and assists with statistical analysis.
- Maintains regulatory binders in accordance with FDA guidelines. Assists research nurse in the preparation of all audits performed by various governing agencies, study monitors, and internal affairs.
- Assures timely submissions of research data, laboratory specimens, and query correspondences to all research affiliates and statistical centers.
- Obtains and maintains valid Dangerous Goods Shipping Certification.
- Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors, Contract Research Organizations, and employees of Hackensack University Medical Center.
Contacts: Regular contact with Medical Center personnel, patients and visitors.
Knowledge, Education and Skills Required:
Bachelor’s degree in Science (Chemistry, Biology, Nursing) or minimum of 3 years extensive experience in research that includes data abstracting, case report form completion and research regulatory reporting.
Knowledge, Education and Skills Preferred:
- Certified Clinical Research Professional (CCRP) certification and/or Certified Clinical Data Manager (CCDM).
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all responsibilities, duties and skills required.
Human Resources Evaluation Results (For Human Resources Internal Use Only):
Approved Job Code:
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