Experienced CRA - Vaccine

Thermo Fisher Scientific • New York, NY

396d • Hybrid

About The Position

As an Experienced Clinical Research Associate (CRA) at Thermo Fisher Scientific, you will play a crucial role in the clinical monitoring and site management process for vaccine-related clinical trials. This position involves conducting both remote and on-site visits to ensure compliance with protocols and regulations, managing documentation, and collaborating with investigative sites to enhance the quality and efficiency of clinical studies. You will be part of a global team dedicated to improving health outcomes through innovative clinical research.

Requirements

• Bachelor's degree in a life science related field or Registered Nursing certification.
• Must have Vaccine experience.
• CRA (Level II): 1+ years as a clinical research monitor.
• Sr CRA (Level I): 2+ years as a clinical research monitor.
• Sr CRA (Level II): 3+ years as a clinical research monitor.
• Principal CRA: 5+ years of clinical research monitoring experience with high expertise.
• Valid driver's license where applicable.

Nice To Haves

• Proven clinical monitoring skills.
• 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 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.
• 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 to ensure compliance with protocols and regulations.
• Perform trial close out and retrieval of trial materials.
• Ensure essential documents are complete and compliant with ICH-GCP and applicable regulations.
• Provide trial status tracking and progress update reports to the Clinical Team Manager.
• Facilitate effective communication between investigative sites, clients, and project teams.
• 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.

Benefits

• Competitive remuneration and annual incentive plan bonus.
• Healthcare and a range of employee benefits.
• 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) 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
• Number of Employees: 10,001+ employees