Sr Clinical Research Associate (CRA)/Principal CRA - Cell or Gene Therapy

Thermo Fisher Scientific • Columbus, OH

409d • $82,800 - $160,000 • Hybrid

About The Position

The position is for an experienced Clinical Research Associate (CRA) at Thermo Fisher Scientific, focusing on monitoring clinical trials related to cell and gene therapy. The role involves both remote and on-site monitoring of investigator sites, ensuring compliance with protocols and regulations, and managing documentation. The CRA will work within a global team to support clinical trials from start to finish, contributing to the development of life-changing therapies.

Requirements

• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent.
• For Sr CRA (Level I): Comparable to 2+ years as a clinical research monitor.
• For Sr CRA (Level II): Comparable to 3+ years as a clinical research monitor.
• For Principal CRA: Comparable to 5+ years of clinical research monitoring experience with a high level of expertise in all aspects of clinical monitoring.
• Valid driver's license where applicable.

Nice To Haves

• Proven clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Ability to manage Risk Based Monitoring concepts and processes.
• Good oral and written communication skills.
• Good organizational and time management skills.
• Effective interpersonal skills.
• Good computer skills, including solid knowledge of Microsoft Office.

Responsibilities

• Perform and coordinate all aspects of the clinical monitoring and site management process.
• Conduct remote and on-site visits to assess protocol and regulatory compliance.
• Manage required documentation and ensure data accuracy through various review processes.
• Document observations in reports and letters in a timely manner using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management and follow through to resolution.
• Maintain regular contact with investigative sites to confirm protocol adherence and issue resolution.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process and ensure shared responsibility on issues resolution.
• Initiate clinical trial sites according to relevant procedures and ensure compliance with protocols and regulations.
• Perform trial close out and retrieval of trial materials, ensuring essential documents are complete and in place.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM).
• Facilitate effective communication between investigative sites, the client company, and the PPD project team.
• Respond to company, client, and applicable regulatory requirements/audits/inspections.
• Complete administrative tasks such as expense reports and timesheets in a timely manner.

Benefits

• Choice of national medical and dental plans, and a national vision plan.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO) and 10 paid holidays annually.
• Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave).
• Accident and life insurance, and short- and long-term disability.
• Retirement and savings programs, including a competitive 401(k) U.S. retirement savings plan.
• Employees' Stock Purchase Plan (ESPP) allowing purchase of company stock at a discount.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree