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Clinical Trial Assistant

4 months ago

Cambridge, United States Vericel Corporation Full time

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing clinical professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Clinical Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

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**DUTIES AND RESPONSIBILITIES**

**Essential Functions**:

- Prepares investigator site files, trial master files (TMF) and electronic trial master files (eTMF) for the initiation of participating centers in clinical studies.
- Collects, registers and archives information and documents in accordance with the applicable good clinical practice guidelines for clinical studies.
- Reviews and analyze clinical trial documentation to ensure accuracy, completeness and compliance with regulatory standards and organizational guidelines.
- Collaborates with clinical research teams, investigators, and other stakeholders to resolve documentation discrepancies and ensure data integrity.
- Works closely with the Clinical Project Manager and is mentored to uphold a strong project foundation and support during challenges.
- Maintains comprehensive documentation of all clinical trial activities, including protocols, informed consent forms, case report forms, and study reports.
- Assists in the development and implementation of document management systems and processes to streamline document workflows and enhance efficiency.
- Performs quality control checks on clinical trial documentation to identify errors or inconsistencies and implement corrective actions as necessary.
- Provide ongoing status reports to the Clinical Project Manager to align on project metrics.
- Supports the Clinical Department in Administrative tasks and meeting department and project deadlines.
- Takes on department-wide tasks to contribute to the optimization of processes within the department.
- Supports the Clinical Project Manager with vendor negotiations.
- Provides support during regulatory inspections and audits by preparing and organizing documentation for review.
- Stays updated on relevant regulations, guidelines, and best practices in clinical research documentation to ensure compliance and continuous improvement.
- Participates in cross-functional team and training initiatives to promote knowledge sharing and collaboration across the organization.

**Leadership Responsibilities**:

- Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

**QUALIFICATIONS, EDUCATION AND EXPERIENCE**

**Basic Qualifications**:

- Associate’s degree in life sciences, health informatics, or related field. Bachelor’s degree preferred.
- Minimum 2 -5 years in clinical research, documentation management, preferably in a research or healthcare setting.
- Strong understanding of regulatory requirements and guidelines governing clinical trial documentation (e.g., ICH-GCP, FDA regulations)
- Excellent communication skills with the ability to effectively collaborate with diverse stakeholders and convey complex information clearly and concisely.
- Detail-oriented with strong analytical and problem-solving abilities.
- Ability to work independently and prioritize tasks in a fast-paced environment while maintaining high standards of accuracy and quality.
- Certification as a Clinical Research Associate (CCRA) is preferred but not required.

**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._