Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients’ homes. By leveraging the latest innovations in mobile technology, cloud services, telemedicine, and mass-engagement channels like Facebook and Google, we are breaking down traditional geographic barriers to patient trial participation while shortening the time needed to bring new treatments to market.
We value employee well-being and aim to provide team members with everything they need to succeed. Enjoy daily healthy catered lunches, snacks and beverages, and top-notch equipment such as the latest Macbook Pro, 4k monitors, and adjustable standing desks.
The Senior Clinical Research Coordinator fulfills the requirements of recruiting, enrolling and conducting follow-up of study participants in clinical trials related to Diabetes, Neurology and Psychiatry. In doing so, the Senior Clinical Research Coordinator is responsible for coordinating trial participation of study volunteers with the trial’s protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.). The Clinical Research Coordinator is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol.
- Under direct supervision of a principal investigator, is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants in clinical trials.
- Collaborates with study investigator in determining eligibility of potential participants in clinical trials.
- Screens potential participants for protocol eligibility. Presents trial concepts and details to the participant, participates in the informed consent process, and enrolls participants in study protocol.
- Ensures research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
- Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide participants education regarding medication administration. Maintains investigational drug accountability.
- In collaboration with the study investigator, reviews study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
- Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
- Maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements.
- Ensures the completion and maintenance of consent forms, case report forms, SAE’s and source documents to ensure that research is being conducted according to guidelines.
- Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives.
- Maintains regulatory documents in accordance with SOPs and applicable regulations.
- Prepare, submit, and maintain IRB approval materials.
- Participates in required training and education programs. Responsible for education of other personnel and vendors regarding clinical research.
- Will collaborate with Project Manager to ensure compliance to trial procedures and vendor management.
- Additional responsibilities may include working directly with other vendors and/or sponsors.
- Provide a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.