Clinical Research Coordinator

Science 37’s mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; Direct-to- Patient Site and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration.

The Clinical Research Coordinator II 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 II 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 II is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol. 

DUTIES AND RESPONSIBILITIES

Duties include but are not limited to:

1. Actively participates in the implementation and execution of clinical trial activities from study start-up preparations, planning, execution and closure.
2. Attends investigator, project and department meetings/trainings, leads as needed, and assists in gathering agenda topics and creating meeting minutes as required.
3. Participates as temporary Project Manager for smaller studies, as needed, with appropriate training/support.
4. Under direct supervision of a Principal Investigator, is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants in clinical trials.
5. Collaborates with study investigators in determining eligibility of potential participants in clinical trials.
6. 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.
7. 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.
8. 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. 
9. Coordinates patient care in compliance with protocol requirements. May provide participants education regarding medication administration. Maintains individual participant investigational drug accountability.
10. 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.
11. Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
12. 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. 
13. 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.
14. Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives.
15. Supports the maintenance of regulatory documents in the ISF in accordance with SOPs and applicable regulations.
16. Participates in required training and education programs. Assists with education of other personnel and vendors regarding clinical research.
17. Collaborates closely with Project Manager to ensure compliance to trial procedures and vendor management.
18. Provides process improvement solutions and collaborates on the implementation of the solutions.
19. Additional responsibilities may include working directly with other vendors and/or sponsors. 
20. 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.
21. Provides mentorship and training for other CRCs as needed.
22. Provides assistance to and creates a supportive environment for the CRC team.

DUTIES AND RESPONSIBILITIES FOR HYBRID TRIALS

1. Acts as a point of contact for the site and Sponsor, as necessary, with oversight from the Project Manager.
2. Develops project plan outlining planning, execution and closeout processes.
3. Develops the study communication plan in collaboration with the sites.
4. Collaborates with the Science 37 study team and extended members to ensure compliance to trial procedures. 
5. Collaborates with Science 37 multi-disciplinary teams to provide clear direction and processes for site study teams and assist with study execution.
6. Other duties, as assigned.

QUALIFICATIONS & SKILLS

Qualifications 

The following qualifications are preferred and/or equivalent applicable experience:

1. 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.
2. A minimum of 5 years of pharmaceutical-sponsored clinical research experience is required or commensurate education, training, and experience within the clinical research field. 
3. ACRP (CCRC) or SoCRA (CCRP) certification, highly desired
4. Medical and scientific knowledge, preferred.
5. Experience working with patients in a HIPAA regulated environment and knowledge of good clinical practice (GCP), and applicable regulatory requirements.
6. Excellent time management, organizational skills and ability to manage multiple tasks.
7. Attention to detail and accuracy in work.
8. Must have the ability to conduct collaborative interaction with cross functional team members.

Skills/Competencies

1. Expertise in trial management - Demonstrated ability to successfully manage the participation of patients in clinical trials. Proactive problem-solving abilities and follow through. 
2. Expert Knowledge of FDA regulations and GCP guidelines – Understands applicable regulations and implications for trial participation.
3. Expert knowledge of clinical research - Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. 
4. 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.
5. 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. 
6. 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. 
7. 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 

1. Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed
2. Ability to communicate in English (both verbal and written)
3. May require extended or unusual work hours based on research requirements and business needs.

BENEFITS 

At Science 37, our focus is to provide you with a comprehensive and competitive total reward package that supports you at all stages of your career - both now and into the future. Our success depends on the knowledge, capabilities, and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work that adds to your professional development.

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. 

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.

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