Clinical Research Coordinator
The 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 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.
Duties include but are not limited to:
- 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 regulatory documents in accordance with SOPs and applicable regulations.
- Prepares, submits, and maintains 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.
- Bachelor’s degree preferred; Advanced degree suggested or equivalent clinical research experience.
- At least 2+ years of pharmaceutical-sponsored clinical research experience or equivalent applicable experience and/or clinical research background.
- Medical and scientific knowledge preferred.
- Experience in the following therapeutic areas preferred/a plus: Diabetes, Neurology and Psychiatry.
- Expertise in trial management – demonstrated ability to successfully manage the participation of patients in clinical trials. Proactive problem solving abilities and follow through.
- Extensive Knowledge of FDA regulations and GCP guidelines – Understands applicable regulations and implications for trial participation.
- Extensive knowledge of clinical research– Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities.
- Strong communication and presentation skills – Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive study participant, project team member and internal Science37 relationships. Ability to interact with patients and caregivers in a compassionate and empathetic manner.
- Computer skills – Working knowledge of MS Office suite and Google applications. Able to generate business correspondence, create forms and generate reports as required. Willingness to gain expertise in the use of propriety software.
- Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done. The ability to adapt to a rapidly changing work environment. Able to successfully work in a decentralized team environment. Skilled in situational responsive decision-making.
- Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed
- Ability to communicate in English (both verbal and written)