Atlantic Research Group is looking to hire a Clinical Research Coordinator to join our growing team. This position is located in Hackensack, NJ. Do you enjoy the thought of playing a major role on the clinical trial management side of an exciting therapeutic study? If so, this opportunity may be for you.
The Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant study conduct according to all relevant local, federal, and state regulatory and institutional Policies and Standard Operating Procedures. The Clinical Research Coordinator carries out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which they are assigned. The below list of duties (listed in order of importance) will give you a view of your day-to-day responsibilities.
- Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol
- In collaboration with the principal investigator and clinical team participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study
- Reviews study with principal investigator and/or clinical research nurses to a budget outlining standard of care and research costs
- Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
- Oversee subject enrollment and ensures that informed consent is properly obtained and documented
- Coordinates research activities including by not limited to: scheduling laboratory or radiology testing, subject appointments, inpatient stays and/or other medical exams as required by protocol.
- Works with the study team to draft/create study specific study orders, billing templates and study calendars as necessary
- Monitors all study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies
- Register protocol patients with appropriate statistical centers as required
- Track enrollment status and document subject early termination data i.e. causes and subject contact efforts
- Works closely with clinical research finance to ensure clinical trial related activities are billed appropriately
- Schedules, coordinates, prepares, and supports monitor site visits and ensures all supporting documentation records are adequate and available for the visit
- Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data
- Ensures compliant maintenance of all required records of study activity including case report forms, drug dispensation records, or regulatory forms
- Oversees and directs the requisition, collection, labeling, storage, or shipment of specimens
- Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups
- Prepare study-related documentation such as protocol worksheets, procedure manuals, adverse event reports, institutional review board documents, and progress reports
- Identify and communicate to investigators protocol issue and assist in problem resolution such as revisions and/or amendments
Knowledge, Education and Skills:
- Bachelors Degree in the Life Sciences required
- 3-5 years clinical research experience or other relevant work experience
- Must complete mandatory education on human subjects research within 30 days of hire
- Proficiency in Hospital Electronic Medical Records preferred
- Clinical Trial Experience in Oncology preferred
- FDA, GCP, OHRP Regulatory Experience preferred
ARG is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. ARG also complies with all work authorization and employment eligibility verification requirements and is an E-Verify employer.