Clinical Research Specialist in Medical Aesthetics

Roles and Responsibilities of Clinical Research Coordinator (CRC)

• Facilitates and coordinates the daily clinical trial activities as a leader for other coordinator and play a critical role in the conduct of the study.
• Schedules study subject appointments and serves as the patient liaison to the PI and other participating physicians.
• Reviews and comprehends each assigned protocol including study proceedings and timelines.
• Working closely with the PI, CRC participates in an integral way in the informed consent process by communicating clearly with potential study subjects about protocol. Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol in order to be able to answer all questions pertaining to the study posed during the informed consent process.
• Coordinates approval of new study agreements and contracts with the IRB and Sponsors.
• Coordinates and attends sponsor Site Selection visits, Routine monitoring visits, and study close out visits.
• Completes case report forms. Extracts data from patient file (Source documents) in a timely manner.
• Responds to data clarification requests in a timely manner.
• May attend Investigator meetings requiring travel and report pertinent information back to research team members.
• Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study, like study protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training.
• Maintains subject screening logs and protocol deviation logs.
• Maintains a excel sheet, tracking updates to database of all subjects enrolled on clinical trials.
• Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits.
• Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations.
• Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis.
• Ensures that all materials for each clinical trial protocol are available for subject enrollment.
• Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure protocols are followed and that there is timely documentation and submission of study data.
• Performs specimen processing and shipment of biological specimen duties.
• Assists with development of study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.
• Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer.
• Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research
• Phlebotomy experience preferred

Job Type: Full-time

Pay: $26.00 - $36.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• Clinical Research Coordinator: 3 years (Required)

Shift availability:

• Day Shift (Preferred)

Work Location: In person

Salary : $26 - $36