Cancer Care Specialists is seeking a Clinical Research Coordinator. The Clinical Research Coordinator (CRC) is a health professional possessing analytical and communication skills, knowledge of FDA/GCP/NIH guidelines, knowledge of IRB policies and procedures, knowledge of data management activities and a willingness to cooperate as a team member. The CRC is responsible for planning and management of the approval, implementation and conduct of research protocols from planning through completion and reporting, assuring that the processes, integrity and quality of the research are assessed and maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, CCS Policy and Procedure and research protocols. Serves as a resource for inquiries and maintains communication with the Investigators, participants, sponsors, IRBs, and other research related entities. Functions as a departmental resource in research operations.
Responsibilities:
- Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research, and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research. Compliantly, accurately and proficiently prepares, processes and manages new research proposals, amendments, continuing review applications, and adverse event reports.
- Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures. Participates in data quality assurance reviews
- Continually revises operating procedures to assure quality and human subjects protection
- Knowledge of IRB policies and procedures
- Knowledgeable of the safety reporting requirements of the study protocol, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes
Qualifications:
- Associate degree or Equivalent Experience
- Proficient in Microsoft Office
- Can communicate effectively by email and phone
- Possess strong organizational skills
Job Type: Full-time
Pay: $49,920.00 - $58,240.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Retirement plan
- Tuition reimbursement
- Vision insurance
Schedule:
- 10 hour shift
- 12 hour shift
- 8 hour shift
- Day shift
- Monday to Friday
- No nights
Work Location: In person
