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Clinical Research Coordinator

4 months ago

East Brunswick, United States Astera Full time
Why Join Us?

For us, what matters most is excellence. We are caring professionals, people who live, work and dedicate themselves to the communities of Central New Jersey. As such, we strive to provide a sanctuary of excellence, precision, thoroughness and genuine compassion. We also take a whole-person approach to patient care and treatment, tailoring all that we do around their unique needs. And we do all we can for patients, going the extra mile to see that they're supported, informed and getting the one-on-one care and service they deserve.

Job Description:

As an Oncology Clinical Research Coordinator (CRC), you will be an integral part of studies at Astera Cancer Care by recruiting participants, collecting and managing the study data for the successful management of clinical trials. This is a full-time position.

Responsibilities Include:
  • Provide overall coordination of study-related activities for patients enrolled in cancer research studies through the Astera research program.
  • Coordinate with Principal Investigators, Supervisor and study sponsors and CROs to ensure that clinical research activities are performed in accordance with local and federal regulations and adhere to policies and procedures of Astera and the sponsors and CROs.
  • Assist in the coordination of tests and visits for patients and collaborate with the Astera study team to maximize work efficiency and productivity.
  • Assist in IRB submissions and interact with the Supervisor to maintain regulatory documents and administrative files for each protocol.
  • Work with research nurses, treating physicians, and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and enrollment into clinical trials.
  • Maintain patient and regulatory research records.
  • Confer with all members of the clinical team to confirm appropriateness and timeliness of tests.
  • Collect follow-up data on patient's post-treatment as required by the protocol.
  • Submit weekly reports to Supervisor, tracking patient screening/enrollment and subject status.
  • Enter research data into a centralized database as per protocol requirements.
  • Attend investigator meetings as required or requested by the Principal Investigator.
  • Prepare other study materials as requested by the Principal Investigator such as informed consent documents, case report forms, enrollment logs and drug/device accountability logs.
  • If applicable, able to prepare blinded and unblinded study drugs.
  • If applicable, act as primary coordinators for unblinded team.

Qualifications:
  • A Bachelor's degree or equivalent working experience required
  • Pharmacy Technician certified with infusion drug preparation training preferred.
  • At least one (1) year of clinical research experience, Oncology experience a plus.
  • Experience in Oncology Patient Recruitment and retention skills.
  • Experience with EDC, IWRS. CRF and Microsoft applications.
  • Able to travel between offices within the offices in Northeast Jersey area.
  • Excellent communication skills.
  • Excellent time management skills.