CRA to Sr.CRA Home-based/Hybrid

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Join Thermo Fisher Scientific and make a positive global impact. Our mission is to enable customers to improve health outcomes worldwide. We provide resources to help you achieve your career goals while advancing life-changing therapies through research and development. With our PPD clinical research portfolio, we conduct clinical trials in 100+ countries and innovate in laboratory, digital, and decentralized clinical trial services.

At PPD® clinical research services, our Clinical Operations colleagues provide end-to-end assistance for clinical trials on a global scale. We handle study start-up, monitoring, and study closeout, working on both commercial and government contracts. Our focus is to collaborate with clients in defining and advancing clinical programs, minimizing delays, and ensuring the delivery of high-quality and cost-efficient clinical studies.

Responsibilities

• Monitors investigator sites with a risk-based monitoring approach.
• Ensures data accuracy through SDR, SDV, and CRF review.
• Assesses investigational products through inventory and records review.
• Details observations using approved business writing standards.
• Advances deficiencies to clinical management promptly.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process.
• Provides trial status tracking and progress updates to the Clinical Team Manager.
• Ensures study systems are updated per agreed study conventions.
• Participates in investigator meetings as necessary.
• Identifies potential investigators in collaboration with the client company.
• Initiates clinical trial sites according to relevant procedures.
• Ensures trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place.
• Conducts on-site file reviews as per project specifications.
• Contributes to the project team by assisting in preparation of project publications/tools.
• Performs additional study tasks as assigned by CTM.
• Facilitates effective communication between investigative sites, the client company, and the PPD project team.
• Responds to company, client, and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets timely.
• Contributes to other project work and initiatives for process improvement.
  
  

Qualifications

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years as a clinical research monitor).
• Valid driver's license where applicable.
• Bachelor's degree or equivalent experience in a life sciences related field or a Registered Nursing certification.
• Effective clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations, and procedural documents.
• Well-developed critical thinking skills.
• Ability to manage Risk Based Monitoring concepts and processes.
• Effective oral and written communication skills.
• Ability to maintain customer focus through good listening skills and attention to detail.
• Effective interpersonal skills.
• Strong attention to detail.
• Effective organizational and time management skills.
• Flexibility and adaptability in a wide range of scenarios.
• Ability to work in a team or independently as required.
• Good computer skills: proficient knowledge of Microsoft Office.
• Good English language and grammar skills.
• Good presentation skills.
• Our 4i Values:
  
  

Integrity – Innovation – Intensity – Involvement

• Our Mission:
  
  

Our Mission is to enable our customers to make the world healthier, cleaner and safer.