At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).
Position Summary:
The Lead Clinical Research Associate (CRA) oversees and manages clinical research projects and is responsible for ensuring that clinical trials are conducted in compliance with regulatory guidelines, Vericel Corporation requirements, and internal policies. This role requires a deep understanding of clinical trial protocols, monitoring practices, and team leadership to drive the success of clinical trials from initiation to close-out.
Schedule:
As a company that thrives on teamwork and face-to-face collaboration, Vericel follows a hybrid schedule with in-office days Monday - Thursday in our new Burlington, MA location, and flexibility to work remotely on Fridays.
Position Scope:
- Oversee and manage the planning, execution, and close-out of clinical trials.
- Serve as the primary point of contact for the clinical trial team and external stakeholders.
- Provide expert guidance to Clinical Research Associates (CRAs) and ensure effective monitoring across multiple sites.
- Ensure the appropriate selection, initiation, and management of clinical trial sites.
- Perform monitoring visits as needed to ensure proper implementation of the clinical protocol, and adherence to GCP, ICH, and FDA regulations.
- Perform co-monitoring visits to provide monitoring oversight.
- Lead CRA meetings and follow up on issues ensuring timely resolution of action items.
- Review and verify site-level clinical data, case report forms (CRFs), and other study documents for accuracy and completeness.
- Lead 3rd party CRAs to ensure a high level of performance and proficiency.
- Conduct training sessions and provide ongoing support to team members on study protocols, regulatory guidelines, and best practices.
- Support development of Standard Operating Procedures, study plans and templates.
- Foster a collaborative and efficient work environment across clinical operations.
- Ensure timely and accurate completion of clinical trial documentation, including monitoring visit reports, site evaluations, and regulatory submissions.
- Review and approve the preparation of study-related reports and documentation.
- Assist in preparing study metrics and progress reports for senior management.
- Review site performance metrics and operational data to ensure study milestones and objective.
- Track protocol deviations and trends, ensure sites are retrained when necessary.
- Ensure that clinical trials are conducted according to GCP, ICH, and regulatory guidelines.
- Actively contribute to the implementation of corrective actions to address issues identified during site visits, audits, or inspections.
- Ensure proper handling, storage, and disposal of clinical trial materials, ensuring compliance with protocols and regulations.
- Assist in the management of site budgets.
- Ensure proper documentation and reporting of adverse events and serious adverse events in accordance with study protocol and regulatory requirements
- Collaborate with cross-functional teams to streamline the workflow and meet study timelines.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field. Advanced degree (e.g., Master's or Ph.D.) is a plus.
- Minimum of 5 years of clinical research monitoring experience with at least 2 years in a leadership role.
- Proven experience in managing and monitoring clinical trials from initiation through close-out.
- Strong knowledge of GCP, ICH, and FDA regulations.
- Demonstrated ability to lead and manage cross-functional teams and mentoring junior staff.
- Excellent leadership, interpersonal, prioritization, and communication skills.
- Strong analytical and problem-solving abilities.
- Ability to effectively manage multiple priorities and meet deadlines.
- Proficiency with clinical trial management systems (CTMS) and other clinical software (e.g., Electronic Data Capture (EDC) platforms.
- Detail-oriented, with the ability to maintain high standards of accuracy and quality.
- Ability and willingness to travel, depending upon project need (occasionally up to 20% domestically).
- Flexibility in work hours is needed to accommodate site visits and meetings across time zones.
Why Vericel?
- Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
- Career Growth: Be a part of a growing organization with opportunities to expand your impact.
- Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.
EEO Statement
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.
