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Clinical Research Coordinator
1 month ago
Vitalief is a pioneering consultancy addressing the healthcare human capital epidemic. Join us and help clients adapt to evolving requirements in the research and clinical trial industry with cutting-edge solutions.
Reasons to Work for Vitalief:
- Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.
- We give everyone a seat at the table - we encourage innovation.
- We're committed to our employees - you are encouraged and mentored by the talented Vitalief team to achieve full potential.
- "Life/Work" balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.
- Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.
Work Location: Work is 5 days per week on-site in Newark, NJ.
Job Responsibilities:
- Under the direct supervision of the Nurse Manager of Clinical Research Center (CRC), you will be responsible for performing a wide variety of tasks to ensure successful Oncology related clinical trials.
- Manage eligibility check lists, perform patient screening/consenting (informed consent), patient activation and managing patient care (patient retention).
- Assist with monitoring patient visits.
- Track deviations and documenting SAEs (serious adverse events).
- Ship specimens to central labs or research labs.
- Track data queries and prepare data for an upcoming audit.
- Work collaboratively with all team members (i.e., physicians, nurses, hospital, and laboratory staff) to ensure that services are coordinated and delivered to patients in a timely manner.
- Minimum of 1 to 2 years of experience in Clinical Research as a Clinical Research Coordinator, with experience in patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance and data management.
- Bachelor's Degree required.
- Any experience in Oncology and/or working on complex clinical trials is a plus.
- Ability to work on 12 to 15 concurrent trials - must have strong organizational and prioritization skills.
- The keys to success in this role are your ability to demonstrate your versatility, "can do" attitude, and adaptability.
- Considerable understanding of Good Clinical Practice (GCP) guidelines.
- Experience in preparation of documents for submission to the Institutional Review Board (IRB), continuing reviews, and submission of amendments and modifications.
- Experience ensuring Serious Adverse Events (SAEs) are completed and reported to the QA Manager and sponsor, if necessary, within reporting deadlines outlined in the protocol.
- Any exposure to EPIC (Electronic Health Records system) and/or OnCore (Clinical Trials Management System) is a plus.
PHYSICAL DEMANDS: Standing, sitting, walking, talking, hearing, and visual perception. Lifting up to 25lbs.
IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that requires all on-site resources such as prospective Vitalief consultants to provide proof that they are fully vaccinated for Covid-19; inoculated annually for Influenza; and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.
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