The Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC will complete all study related procedures and distribute study medications and instructions to research subjects under the direction of the Investigators, Clinic staff, CROs and Sponsors. They will maintain accurate confidential files and documentation of the study participants. The CRC will also engage in the explanation of what is expected of the research subjects and understand their concerns, requiring excellent interpersonal and communication skills. All duties are carried out in accordance with the company policies, SOPs, and Good Clinical Practice (GCP) as well as all applicable local, State and Federal regulations.
Reviews study protocols and complete study trainings becomes familiar with them.
Ensures they receive access, approvals, and study supplies i.e., lab kits, study medication, diaries, questionnaires, rates training approval, IRB approvals including but not limited to ICF English/Spanish protocol approval recruitment materials are on site prior to initiation.
Attends IM, SIV and any other training session required by the sponsor.
Develops their own source documents following sites template and gives them to their direct supervisor for approval.
Meets with the Regulatory Department to ensure that the study is captured correctly in the system including the window period frequency of study visits and verifies the patient stipend injects the same amount as the ICF.
Performs a meeting with the laboratory personnel and assistants coordinator(s) (if applicable) prior to initiation of the study to train them on the protocol.
Makes sure that all personnel listed on the Delegation Log have completed all the trainings required by sponsors.
Reviews each tab of the Regulatory Binder including but not limited to 1572, Delegation Log, Temperature Log, FDF, CVs, Medical Licenses, Etc.
Conducts, organizes and ensures compliance of clinical research trial according to protocol stipulated regulations, INDAGO RESEARCH & HEALTH CENTER SOPs, GCP guidelines.
Consents and must enter each subject per GCP/Protocol guidelines.
If data entry personnel are not available, the CRC enters subject data in EDC within 24 hours of the visit being performed.
Keeps site system and imports up to date regarding subject status in trial.
Ensures all deviations, violations, AEs, SAEs are captured, recorded, followed, and reported to sponsor/IRB in a timely manner.
Performs study related procedures in compliance with protocols including but not limited to drug dispensation, compliance and drug accountability, vital signs, phlebotomy, ECG, questionnaires, and surveys.
Records visits in IVRS/IWRS on the same day of the visit.
Meets INDAGO RESEARCH & HEALTH CENTER, Inc.'s expected enrollment, retention, screens failure goals.
Ensures that the laboratory is following protocol requirements and that all samples are successfully packed and sent to the central/local laboratory as indicated.
Ensures proper follow up of subjects that have missed their appointments until they come back for their visit or are declared LTFU or withdrawal.
Reviews with the receptionist, lab personnel and the assistant CRC that the subjects that are scheduled the following day.
Stays up to date by doing individual research on new guidelines of the Regulatory Agencies.
Resolves any CRA queries before the monitored visit is over.
Resolves any pending action items within 7 days of the monitored visit.
Assists monitors during the monitoring visit or remote monitoring visit.
Maintains PI/Sub-Is/Lead CRC always informed on all aspects of the trial by giving them copies of but not limited to all follow-up letters, sponsor/IRB relevant correspondence, brings lab alerts AE, SAE to their attention.
Works extra hours, weekends or holidays when required.
Completes additional tasks as required by a specific protocol.
Indago Research & Health Center, Inc. strives to provide a community-based service for our trial participants and reliable data to our clinical trial sponsors. By doing so, we not only help meet our sponsors’ goals by helping advance understanding in the field of Investigational New Drugs (IND), but we also aid in the research and discovery of more effective medicines for the prevention, treatment and cure of human illness.
The company observes all laws and U.S. treaties governing clinical trial studies (Internal Conference of Harmonization; Code of Federal Regulations) in compliance with the Good Clinical Practice Guidelines. We strive always to protect the rights of our trial participants by safeguarding their integrity as expressed in the Declaration of Helsinki as well as strictly protecting their confidential information pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). We expect no less of our employees.
As an employee, you are critical to the continuing success of our business by helping us provide the highest quality of service to our clinical trial sponsors in the conduct of each study and the treatment and rights of each participant.