Clinical Research Associate II - US East Region (Northeast & Southeast) - Multiple Therapeutic Areas Available

Work Schedule

Standard (Mon-Fri).

Environmental Conditions

Office environment.

Job Description

Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation

We have supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last five years. As part of our global team, you’ll 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 are described below.

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.
• 1 year of experience as a clinical research monitor or completion of the PPD Drug Development Fellowship (or equivalent).
• 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, Ophthalmology, Neurology, Cardiology, Rare Disease, Respiratory, Obesity, and/or Pulmonary.
• 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.
• Understanding of medical/therapeutic area knowledge and medical terminology.
• Ability to attain and maintain working knowledge of ICH-GCPs, applicable regulations, and procedural documents.
• Strong critical thinking skills, including root cause analysis and problem solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Good oral and written communication skills; ability to communicate effectively with medical personnel.
• Customer focus with strong listening, attention to detail, and the ability to perceive underlying issues.
• Strong organizational and time management skills.
• Effective interpersonal skills and attention to detail.
• Flexibility and adaptability in a wide range of scenarios.
• Ability to work in a team or independently as required.
• Proficiency with Microsoft Office and the ability to learn appropriate software.
• Strong 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 equipment.
• Frequent travel to site locations; generally 60–80% travel, with extended overnight stays possible.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Personal protective equipment such as protective eyewear, garments, and gloves may be required.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Compensation and Benefits

The salary range estimated for this position based in Florida is $85,000.00–$130,000.00.

This position may also be eligible to receive 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:

• 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