Clinical Research Associate
Job Title: Clinical Research Coordinator
The Clinical Research Coordinator, as delegated by the principal investigator, executes and coordinates daily clinical research activities according to the organizations SOPs, GCP and FDA/ICH guidelines. Ensures IRB approved protocols are implemented and followed. Executes informed consent process and monitors patient status and safety; collects and organizes research data; schedules and conducts study specific training and site in-services to study related staff on new or amended protocols; educates patients and their families about treatments and possible side effects.
The CRC may assist with new staff training and mentoring. The CRC has demonstrated clinical research expertise by optimizing recruitment and enrollment while maintaining a high level of quality.
Additionally, this role seeks to improve the sites operations by providing management with support in change management and process improvement. The CRC typically carries a larger study load and is able to function at a high level of competency with more complex or high enrolling trials. The Clinical Research Coordinator must also be able to perform clinical tasks (i.e. phlebotomy, EKGs, vital signs, etc.).
- Must be able to thoroughly and accurately complete the tasks described in the CRC's job description.
- Utilizes universal precautions, obtains and maintains certification for the handling of potential infectious fluids and maintains safety for self, patient and others around them;
- Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study;
- Adhere to GCP, ICH, HIPAA, NIH, FDA Regulations and SOPs and maintain ongoing regulatory documents;
- Establish rapport with sponsor representatives and maintain frequent face-to-face, written and telephone contact with various persons involved in the study, including but not limited to the patients, relatives/friends of the patients, doctors, pharmaceutical sponsors and all levels of the company;
- Serve as Study Coordinator for a number of clinical trials;
- Manage onsite research protocol activities and assist staff in organization to ensure study protocol procedures and good clinical practices;
- Manage and participate in study recruitment to ensure enrollment goals are met or exceeded and generate reports for supervisor on patient enrollment and tracking;
- Direct and guide Research Assistant on study specific tasks;
- Perform basic lab procedures, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up, schedules patients, obtains informed consent, administers study medications;
- Perform appropriate research protocol procedures which may include, but are not limited to: vital signs, pregnancy tests, blood collection and processing, ECGs, alcohol breath tests and administers pain assessments;
- Ensure study related reports and patient results are reviewed by an investigator in a timely manner;
- Responsible for completion of case report forms, ensuring accuracy of data and reporting of adverse events to sponsor;
- Dispense investigational product and instruct subjects on usage and potential drug interactions;
- Practical knowledge of document processes and reporting of SAEs, 1572s, CRFs, ICFs, etc.;
- Prepare presentations to schedule training for physicians, nurses and staff on research protocol;
- Provide patient education regarding disease process and involve patient and family in decision-making processes;
- Maintain accountability of own ongoing professional growth and development;
- Performs necessary functions as approved by the Investigator and the Company after the completion of required training, for the conduct of clinical research;
- Maintain strict confidentiality of patients, employees and company information at all times and adheres to HIPAA Guidelines;
- Responsible for drug accountability, maintaining logs and inventory of study product and supplies;
- Coordinate and conduct pre-study, initiation, monitoring and close-out visits with the pharmaceutical representative, including completion of minutes and follow-up reports;
- Maintain contact and interact with monitors and sponsors;
- Work under direction of principal investigator;
- Attend investigator meetings; and
- May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.
A Bachelor's degree and a minimum of 2 years of experience as a Clinical Research Coordinator, or an equivalent combination of education and experience, is required. An RN credential is a plus. Certification as a Clinical Research Coordinator is preferred. Licenses. Training, etc: Maintenance of certifications and applicable licenses. Completion of the organizations training and proficiency exams within 6 months of hire.