This is a fully Remote and Work From Home (WFH) opportunity within the US
Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. The Science 37 Operating System (OS) enables universal access to patients and providers, leading to faster enrollment, greater retention and a more representative patient population. To help us achieve our goal, we are seeking a Clinical Research Coordinator eager to make an impact within a mission-driven organization.
The Clinical Research Coordinator fulfills the requirements of recruiting, screening, enrolling and conducting the follow-up of study participants in clinical trials under the supervision of the Principal Investigator (PI). Furthermore, the Clinical Research Coordinator is responsible for the proper conduct of all study activities, as outlined in the study protocol. company 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 Study Management Team to meet enrollment and retention goals and ensure compliance with the study protocol.
DUTIES AND RESPONSIBILITIES
Duties include but are not limited to:
- Metasite or Virtual Trials Duties
- Actively participate in the implementation and execution of clinical trial activities from study start-up preparations, planning, execution, and closure.
- Attend investigator, project and department meetings/trainings, and lead as needed, and assist in gathering agenda topics and creating meeting minutes as required.
- Develop and refine process maps of all stages of Science 37 trials, from the perspective of all stakeholders.
- Develop internal and external stakeholder educational material (Videos, infographics, etc.) to provide a clear understanding of Science 37 trial experiences through the viewpoints of key individuals (Investigator, participant, etc.) involved in study participation and conduct.
- Screen potential participants for protocol eligibility in collaboration with the investigator. Presents trial concepts and details to the participant, participate in the informed consent process, and enroll participants in the study protocol.
- Ensure research quality by practicing in compliance with Science 37 Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
- Ensure that study activities are properly tracked and entered into the company’s time tracking/project management/resource planning software tool in a timely manner.
- Schedule and participate in monitoring and auditing activities.
- Identify, document, and report protocol deviations and potential adverse events to Clinical Study Leader and Investigator.
- Ensure the completion and maintenance of consent forms, case report forms, SAE’s and source documents to ensure that research is being conducted according to the guidelines.
- Maintain regulatory documents in accordance with SOPs and applicable regulations.
- Prepare, submit, and maintain IRB approval materials.
- Collaborate with Clinical Study Leader to ensure compliance to trial procedures and vendor management.
- Collaborate with the Clinical Study Leader and Director(s) of Clinical Operations to provide feedback on process improvement, workflows, and strategic development.
- Participate as interim Clinical Study Leader for smaller studies, as needed, with appropriate training/support.
- Assist and support development, review, and distribution of clinical protocols, informed consent forms, study instructions/manuals/guidelines or department generated tools and other study-related clinical documents.
- Contact and coordinate with the study team, CROs, and vendors for specific requests (e.g., updates, missing documentation, meeting arrangements, etc.).
- Support the maintenance of the Investigator Site File (ISF) – paper and electronic, by scanning, filing, and retrieving clinical trial documents.
- Support document control system and processes, such as performing quality control checks on clinical trial documents and ISF (electronic and hardcopy), as requested
- Assist in review and coordination of site payments, track NDAs, CTAs.
- Perform additional project tasks as determined by the department and organizational needs.
- Hybrid Trials Duties
- Act as point of contact for the site and Sponsor, as necessary, with oversight from the Clinical Study Leader.
- Develop project plan outlining planning, execution and closeout processes.
- Develop the study communication plan in collaboration with the sites.
- Collaborate with the Science 37 study team and extended members to ensure compliance to trial procedures.
- Collaborate with Science 37 multi-disciplinary teams to provide clear direction and processes for site study teams and assist with study execution.
- Comprehensive Duties
- Maintain comprehensive knowledge of assigned research protocol(s) 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.
- Perform timely and accurate data entry into tracking systems/tools and maintains tools in accordance with project requirements and study activities, including collection of information from designated team members, CROs, or other vendors in clinical databases and other associated data tracking tools (e.g., enrollment, essential documents, logs to track study kits, samples, supplies, etc.).
- In collaboration with the study investigator, identify and document changes in health conditions, concomitant medication use, protocol compliance.
- In collaboration with the study investigator, perform the collection, processing, and shipping of research samples (if appropriately certified) as described by the study protocol.
- In collaboration, and under the delegation of the study investigator, obtain biometrics and electrocardiograph measurements (if appropriately certified as described by the study protocol). Adhere to ALCOA expectations in clinical study documentation.
- Establish and coordinate logistical aspects of clinical research projects to achieve project objectives.
- Participate in Clinical Operations Staff Meetings and lead study-specific meetings, as needed.
- Participate in required training and education programs. Educate and mentor other personnel and vendors regarding clinical research.
- 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.
- Representing Science 37 in a professional manner; establishing and maintaining good relationships with investigators and all other study personnel.
- Other duties, as assigned.
QUALIFICATIONS & SKILLS
- Bachelor’s degree (preferred) or minimum two-year college degree, or an equivalent combination of education, training, experience, and demonstrate skills needed to successfully perform the assigned duties and responsibilities.
- 3+ years of relevant investigational research experience in the clinic or pharma/biotech/CRO.
- 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 the 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.
- Expertise in trial management. The ability to successfully manage participants in clinical trials. Proactive problem-solving abilities and follow through.
- Expert Knowledge of FDA regulations and GCP guidelines. Understands applicable regulations, guidelines 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.
- Expert knowledge of the collection of research data (if applicable). Knowledgeable, and Science 37 certified, to perform the collection of research data such as biometrics, research laboratory samples, and electrocardiograph measurements. Documentation of internal certification must be filed in order for this competency to be applicable.
- Strong communication and presentation skills. Demonstrates strong written and verbal communication and presentation skills. Ability to establish and maintain cooperative working relationships with study participants and project team members
- Computer skills. Working knowledge of MS Office suite, Electronic Data Capture Systems, Google applications. Ability to generate business correspondence, create forms and generate reports as required. Willingness to gain expertise in the use of proprietary
- Practices professionalism and integrity in all actions. Ability to foster concepts of teamwork, cooperation, social and self-awareness, and flexibility to get complete assigned tasks. Demonstrates adaptation 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 study visits, training, project team meetings, client presentations and other professional meetings/conferences as needed
- Ability to communicate in English (both verbal and written); fluency in other languages is a plus.
- May require extended or unusual work hours based on research requirements and business needs.
The incumbent reports directly to Director Clinical Operations/Associate Director, Clinical Operations or Clinical Study Lead.
No direct reports
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.
Submit your resume to apply!