Clinical Research Coordinator I

The Clinical Research Coordinator I conduct high quality clinical research following the highest ethical and regulatory standards of care.

Major Duties and Responsibilities

Become familiar with the design of proposed and implemented studies.

Review study protocols to evaluate factors such as sample collection processes, data management plans, and potential risks to subject patients.

Communicate well with patients, medical personnel, research sponsors, and institutional review boards (IRBs).

Assess eligibility of potential subjects through screening interviews, review of medical records, and discussion of patient status with physicians and nurses.

Inform patients and caregivers of study designs, risks, and outcomes to be expected.

Organize sites for study equipment and supplies.

Contact industry representatives to ensure that the equipment and software specifications needed for successful study completion are available.

Attend meetings required by research sponsors; some travel and overnight stays may be required.

Enroll patients in clinical studies, ensuring that informed consent is obtained and documented in accordance with all applicable regulatory and ethical requirements at the federal, state, and local levels.

Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.

Order the drugs and/or devices necessary for studies.

Dispense medication and/or medical devices, calculate dosages, and provide instruction for patients as necessary.

Comfortable handling lab specimens which may include blood, urine, vaginal fluids, joint aspirants, sputum or others.

Competent in the processing, labeling specimen tubes, filling out requisitions, working with dry ice, storing and shipping lab specimens as required.

Collect and maintain study data, which may be either electronic and/or printed, depending on the study.

Obtain subject follow-up information and communicate with health care providers and subjects as necessary.

Register protocol patients with appropriate statistical centers as required.

Prepare and maintain records of study activities, including case report forms, drug dispensation records, and regulatory compliance.

Prepare and maintain study-related protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.

Record adverse events and side effect data and confer with investigators regarding the reporting of events to oversight agencies.

Collaborate with investigators to prepare reports and presentations concerning clinical study procedures, results, and conclusions.

Track enrollment status of subjects, document causes of dropout, and document efforts to contact subjects.

Become familiar with relevant electronic medical records and HIPAA law.

Monitor studies to ensure compliance with protocol design.

Monitor studies to ensure compliance with federal, state and local regulations and TPMG's ethical policies.

Prepare for and participate in audits conducted by study sponsors, federal agencies, and specifically designated review groups.

Maintain contact with sponsors to schedule and coordinate site visits and answer questions about all issues with records or data.

Identify protocol problems, inform investigators of problems, and assist resolution of such problems.

Confer with health care professionals to determine the best recruitment practices for studies.

Develop advertising and other informational materials to be used in subject recruitment.

Meet with physician groups as needed.

Participate in preparation and management of research budgets.

Participate in the billing process for studies and oversee monetary disbursements.

Participate in training and quality assurance programs.

Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical study affairs and issues.

Ability to work well independently and with a team.

Ability to refocus attention easily after multiple interruptions.

Ability to remain organized despite multiple paper charts being utilized at the same time.

Using your own transportation to purchase dry ice for laboratory specimen shipments and taking the packages to USPS, UPS, and or FedEx for delivery as needed.

Willing to perform work related tasks off-site when necessary.

Willing and eager to learn new things.

Other duties as assigned.