Contract - Clinical Research Coordinator

The posting, as Science 37 wrote it

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.

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. 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.

*This is a Contract role with potential to convert to Full Time after 6 months*

DUTIES AND RESPONSIBILITIES

Duties include but are not limited to

• 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. Maintains individual participant investigational drug accountability.
• In collaboration with the study investigator, reviews study participants for changes in condition, adverse events, concomita

[…]
tical 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 rapport, project team members, and internal Science37 relationships. Ability to interact with patients and caregivers in a compassionate and empathetic manner.
• Leadership skills - Demonstrates the ability to communicate effectively across multifunctional teams. Provides effective solutions to challenges. Is recognized by others as a leader and a resource.
• Computer skills - Proficient with MS Office and Google Suite applications. Able to generate business correspondence, create forms and generate spreadsheet reports as required. Demonstrates expertise in the use of proprietary software.
• Practices professionalism and integrity in all actions – Demonstrates 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.

Capabilities

• 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.

Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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