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

Cancer Care Specialists

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Clinical Research Coordinator