Data Coordinator

Exciting career opportunity in Clinical Research. Apply Now for more info!

Description:

Must Haves:

o 2 years - Clinical Research Experience

o Must have 4 year degree (prefer in the sciences)

o Oncology Experience Preferred

Job Summary:

The Clinical Data Coordinator maintains essential study documents for clinical research studies and enters data onto Case Report Forms and ensures study compliance.

1. Prepares reports and assists with statistical analysis.

2. 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.

3. Assures timely submissions of research data, laboratory specimens, and query correspondences to all research affiliates and statistical centers.

4. Obtains and maintains valid Dangerous Goods Shipping Certification.

5. 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.

6. Obtains patient consent for minimal risk studies.

7. 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.

8. Verifies that all patients have provided informed consent prior to entering study specific data.

9. Compares schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs.

10. Records accurate data by completing paper or electronic CRFs.

11. Resolves data queries accurately and within study specific timeframes.

12. Maintain adequate inventory of research supplies necessary for research activities. Ensures supplies and kits are current and safely disposes of expired/closed supplies.

13. Centrifuges human specimens per study specific laboratory manual guidelines.

14. Processes and ships human specimens and biologic agents per protocol guidelines and Federal Regulations.

15. 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.

16. Ensures regulatory binders are maintained with essential study documents.

17. Maintains timely patient follow-up by accurately reviewing the study specific follow-up schedule in the protocol and completes follow-up CRFs.

18. 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.

19. Utilizes the SAE reporting log to track the receipt, submission and acknowledgement of off-site SAEs per protocol.

20. Prepare reports, including but not limited enrollment logs which assists with institutional statistical analysis.

21. Lifts a minimum of 5 lbs., pushes and pulls a minimum of 10 lbs. and stands a minimum of 4 hours a day.

22. Ability to sit and concentrate at a computer workstation for a minimum of 4 hours at a single sitting.

23. 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.).

24. Adheres to the standards identified in the Medical Center's Organizational Competencies.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $60,000 - $70,000