FSP CRA II/ Sr CRA I - Oncology & Gen Med - East Coast/West Coast

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as an FSP Clinical Research Associate (Level II or SR CRA I) – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech, spanning 2,700 clinical trials across 100+ countries in the last five years.

As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.

Education and Experience Requirements

Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor) or completion of PPD Drug Development Fellowship.

Valid driver's license where applicable.

1-2 years of traveling on-site monitoring experience is required.

Therapeutic experience in at least one of the following areas: Oncology, Gen Med (including Respiratory & HIV).

Candidates must live within 60 miles of the nearest major airport. Up to 80% travel is expected.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, including a drug screening.

Knowledge, Skills and Abilities

• Proven clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
• Strong critical thinking and problem-solving abilities, including root-cause analysis
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills and ability to communicate effectively with medical personnel
• Customer focus, active listening, attention to detail, and ability to perceive underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail; ability to remain flexible and adaptable
• Ability to work in a team or independently as required
• Proficient computer skills: Microsoft Office and ability to learn relevant software
• Good English language and grammar skills
• Good presentation skills

Working Conditions and Environment

• Work is performed in an office, laboratory, clinical, and/or home office environment with exposure to electrical office equipment.
• Frequent travel to site locations; typically 60–80%, with extended overnight stays in some cases.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Personal protective equipment required (e.g., protective eyewear, garments, and gloves).
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Compensation and Benefits

The salary range estimated for this position based in Nevada is $85,000.00–$120,000.00.

This position may be eligible for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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 in accordance with company policy
• Retirement and savings programs, such as our 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards