Clinical Research Coordinator

About the role

A Clinical Research Coordinator (CRC) is responsible for reviewing, processing, and managing clinical research data and documents, both regulatory and patient records. The CRC performs a variety of clinical procedures, and assists with daily workload planning; i.e., collect, record, report, and interpret data on patients enrolled in and/or seeking enrollment in clinical studies according to the protocol, SOPs, and GCPs.

This job operates in a professional and clinical environment with occasional visits to other Innovo Research partner sites/clinics. This role routinely uses standard office equipment such as computers, phones, and scanners. There is frequent exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations, and other conditions common to a clinic environment. Varied activities include standing, walking, reaching, bending, and lifting. Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 50 pounds. Requires corrected vision and hearing to normal range. Due to the nature of this position, employees are expected to work in person. This is an exempt position under the federal and state wage and hour laws, which means you are not eligible for overtime pay beyond your salary. Employees are expected to work 40 hours a week. Occasional evening and weekend work may be required as job duties demand. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.

Responsibilities

• Collect, record, and maintain research subject study data according to study protocols and SOPs, preserving quality control for content, accuracy, and completeness.
• Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research.
• Recruit and screen participants for clinical trials and maintain subject screening logs.
• Assist in the initial and ongoing consent process; orient research subjects to the study, including the purpose of the study, procedures, and research process.
• Maintain source documentation based on protocol requirements.
• Schedule and execute study visits and perform study procedures.
• Handle lab testing and analysis, including preparation of specimen collection tubes, shipment, and lab logistics.
• Monitor subject safety and report adverse events/reactions to the Principal Investigator and/or appropriate medical personnel.
• Correspond with research subjects and troubleshoot study-related questions or issues.
• Participate in “huddles” to