Clinical Research Coordinator

Position Title: Clinical Research Coordinator

Summary: This position is responsible for organizing, planning and controlling work flow of all clinical research related activities. The Clinical Research Coordinator is required to have an in-depth knowledge of clinical trial requirements and good clinical practices as set forth by federal regulations. As the primary resource for the clinical trials, the coordinator will act as liaison between the investigators, the institutional review board (IRB), and the study sponsors. Along with the investigator, the research coordinator will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the research coordinator will be responsible for all data and source documentation, adverse experience reporting, and maintenance of complete regulatory files.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

Communications / Liaison:

• Maintain cooperative relationship with co-workers, component hospital departmental staff, investigator medical office staff, study sponsor contacts, and clinical research participants.
• Answer telephone, screen calls, take messages, and provide information to appropriate staff.
• Communicate on a regular basis with investigators and office nurses regarding the availability of clinical studies.
• Act as liaison between investigators and study sponsor staff.
• Maintain cooperative relationship with co-workers, component hospital departmental staff, investigator medical office staff, study sponsor contacts, and clinical research participants.
• Attend component hospital Tumor Board conferences when assigned.
• Communicate needs for laboratory, pathology, and/or radiology submissions.
• Communicate investigational drug orders and schedules to designated pharmacist.

Screening and Enrollment:

• Ascertain that there is documented IRB approval to the IRB for clinical trials prior to registration/randomization
• Review the study design and inclusion/exclusion criteria with the investigator.
• Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility. Review the protocol, informed consent form, and follow-up procedures with potential study subjects if so directed by the investigator.
• Ensure the current approved informed consent and HIPAA agreement form are signed before subjects are screened and enrolled.
• Ensure that the registration/randomization procedure is followed as per protocol guidelines.
• Document record of the subject's registration/randomization as well as data assigned and/or waived by the registering study sponsor.
• Maintain accrual log and spreadsheet of protocol patients.
• Enter registered/randomized subjects into database.
• Calculate and verify protocol treatment drug dosages with a second CRA and the treating investigator.

Subject Follow-up:

• Prepare, maintain, and distribute a subject calendar with treatment schedule, test schedule, and follow-up schedule to ensure adherence to protocol requirements.
• Monitor dosage modifications and treatment calculations.
• Obtain continuous follow-up information on subject's medical status per protocol.
• Assess and record all adverse drug events as outlined in the protocol.
• Report adverse drug events / attribution according to federal and study sponsor guidelines by completing required forms and online data submission.
• Ensure appropriate specimen collection as required per protocol.

Data Management:

• Collate data for submission to meet protocol requirements.
• Abstract data from appropriate sources to complete case report forms.
• Key data for remote data entry or submit completed case report forms per protocol guidelines.
• Maintain source documentation for all case report form entries, including clinic chart visit notes, lab data, radiology reports, pathology reports, operative reports, and hospitalizations.
• Ensure resolution of study sponsor queries in timely manner.
• Review study sponsor delinquency reports for deficiencies.
• Correct and edit case report forms, as appropriate.

Other:

• Assist in training of all new CRAs, chemotherapy nurses, and investigator assigned nurses.
• Assist Pharmacist in ordering investigational drugs, maintaining drug accountability records, and delivery of investigational drugs to satellite offices.
• Assist in internal quality assurance program and routine monitoring audits.
• Participate in presentations or seminars related to the field of clinical research.

Supervisory Responsibilities

• This job has no supervisory responsibilities.

Qualifications:

Education and/or Experience:

• Certified Clinical Research Professional, Registered Nurse, or B.S. in Health Related Field. Equivalent related work experience can be substituted for educational experience. Oncology and/or clinical research experience preferred. Computer experience in Database software, Internet software and Word Processing software preferred.
• Frequent travel to local satellite offices is required. Occasional overnight travel to sponsor meetings is also required for training purposes and updates.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Retirement plan

Work Location: In person