[Hiring] Clinical Research Coordinator @Science 37

Role Description

The Clinical Research Coordinator fulfills the requirements of recruiting, enrolling and conducting follow-up of study participants in clinical trials under the direct supervision of the Principal Investigator (PI) and Project Manager. Responsibilities include:

• Actively participates in the implementation and execution of clinical trial activities from study start-up preparations, planning, execution and closure.
• Attends investigator, project and department meetings/trainings, leads as needed, and assists in gathering agenda topics and creating meeting minutes as required.
• Participates as temporary Project Manager for smaller studies, as needed, with appropriate training/support.
• 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 investigators 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 and advocating for any edit needs of Science 37 Standard Operating Procedures (SOP), and ensures research quality by practicing in compliance with principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
• Supports the development, review and distribution of clinical protocols, informed consent forms, study instructions/manuals/guidelines or department generated tools and other study-related clinical documents.
• Coordinates patient care in compliance with protocol requirements, may provide participants education regarding medication administration, and maintains individual participant 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.
• Supports the maintenance of regulatory documents in the ISF in accordance with SOPs and applicable regulations.
• Participates in required training and education programs. Assists with education of other personnel and vendors regarding clinical research.
• Collaborates closely with Project Manager to ensure compliance to trial procedures and vendor management.
• Provides process improvement solutions and collaborates on the implementation of the solutions.
• Provides 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.
• Provides mentorship and training for other CRCs as needed.
• Provides assistance to and creates a supportive environment for the CRC team.

Qualifications

• Bachelor’s degree (preferred) or minimum two-year college degree, or an equivalent combination of education, training, experience, and demonstrated skills needed to successfully perform the assigned duties and responsibilities. Advanced degree preferred but not required.
• A minimum of 5 years of pharmaceutical-sponsored clinical research experience is required or commensurate education, training, and experience within the clinical research field.
• ACRP (CCRC) or SoCRA (CCRP) certification, highly desired.
• Medical and scientific knowledge, preferred.
• Experience working with patients in a HIPAA regulated environment and knowledge of good clinical practice (GCP), and applicable regulatory requirements.
• Excellent time management, organizational skills and ability to manage multiple tasks.
• Attention to detail and accuracy in work.
• Must have the ability to conduct collaborative interaction with cross functional team members.

Requirements

• Expertise in trial management.
• Demonstrated ability to successfully manage the participation of patients in clinical trials. Proactive problem-solving abilities and follow through.
• Expert Knowledge of FDA regulations and GCP guidelines.
• Expert knowledge of clinical research.
• Strong communication and presentation skills.
• Leadership skills.
• Computer skills.
• Practices professionalism and integrity in all actions.
• 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).
• May require extended or unusual work hours based on research requirements and business needs.

Company Description

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research.