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

Thermo Fisher Scientific-posted about 1 year ago
$82,800 - $130,000/Yr
Full-time • Mid Level
Hybrid • Orlando, FL
Computer and Electronic Product Manufacturing
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The Sr Clinical Research Associate (CRA)/Principal CRA position at Thermo Fisher Scientific focuses on experienced onsite traveling CRAs with expertise in monitoring cell or gene therapy. The role involves conducting remote and on-site visits to ensure compliance with protocols and regulations, managing documentation, and contributing to the success of clinical trials across various locations. This position is integral to the company's mission of enabling customers to improve health outcomes through innovative therapies.

  • 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.
  • 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 investigator meetings and identify potential investigators in collaboration with clients.
  • Initiate clinical trial sites according to relevant procedures to ensure compliance with protocols and regulations.
  • Perform trial close out and retrieval of trial materials.
  • Ensure that required essential documents are complete and in place according to ICH-GCP and applicable regulations.
  • Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM).
  • Facilitate effective communication between investigative sites, clients, and the project team.
  • Respond to company, client, and regulatory requirements/audits/inspections.
  • Complete administrative tasks such as expense reports and timesheets in a timely manner.
  • Contribute to project publications/tools and process improvement initiatives.
  • 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.
  • Valid driver's license where applicable.
  • 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 presentation skills
  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  • At least 120 hours paid time off (PTO), 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, such as a competitive 401(k) U.S. retirement savings plan
  • Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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