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Science 37 · 13 hours ago

Clinical Research Coordinator

Raleigh, NC

Full-time

Hybrid

Senior Level

5+ years exp

Science 37 is dedicated to accelerating clinical research by enabling universal trial access for patients. The Clinical Research Coordinator II is responsible for recruiting, enrolling, and conducting follow-up of study participants in clinical trials while ensuring compliance with protocols and regulations.

BiotechnologyClinical TrialsHealth CareHome Health Care

Responsibilities

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, 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

Additional responsibilities may include working directly with other vendors and/or sponsors

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

Acts as a point of contact for the site and Sponsor, as necessary, with oversight from the Project Manager

Develops project plan outlining planning, execution and closeout processes

Develops the study communication plan in collaboration with the sites

Collaborates with the Science 37 study team and extended members to ensure compliance to trial procedures

Collaborates with Science 37 multi-disciplinary teams to provide clear direction and processes for site study teams and assist with study execution

Other duties, as assigned

Qualification

Clinical research experienceGCP knowledgeFDA regulations knowledgeACRP certificationTime managementOrganizational skillsComputer skillsCommunication skillsLeadership skillsAttention to detail

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

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

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 – Understands applicable regulations and implications for trial participation

Expert 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 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

Preferred

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

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