FSP CRA I & CRA II - Oncology - Respiratory - Cardiovascular - Southeast region

ThermoFisher Scientific; Suwanee (GA); On-site; USD 75,000 - 115,000; Full time

Benefits offered by this job

Medical plans

Dental plan

Vision plan

PTO 120h per year

Holidays

Parental leave

Disability insurance

401(k) plan

ESPP

Job summary

Thermo Fisher Scientific invites you to join as an FSP Clinical Research Associate (Level I & II). You’ll perform and coordinate clinical monitoring and site management, conducting remote or on-site visits to verify protocol and regulatory compliance, and manage required documentation across sponsor environments.

The role requires a life science degree or RN cert, willingness to travel 60–80%, a valid driver's license, and the ability to work in the United States without sponsorship.

Qualifications

• Bachelor's degree in life sciences or RN required.
• Minimum travel monitoring experience (approximately 6 months) required.
• Therapeutic areas: Oncology, Respiratory, Cardiovascular.
• Valid driver's license.
• Candidates must live within 60 miles of the nearest major airport.
• 60-80% travel is expected.
• Must be legally authorized to work in the United States without sponsorship.
• Must pass a comprehensive background check, including a drug screen.

Responsibilities

• Perform and coordinate all aspects of clinical monitoring and site management.
• Conduct remote or on-site visits to assess protocol and regulatory compliance.
• Manage procedures and guidelines from different sponsors and monitoring environments.
• Ensure trial is conducted per approved protocol, ICH-GCP, regulations and SOPs.
• Develop collaborative relationships with investigational sites and ensure audit readiness.

Skills

Clinical monitoring

ICH-GCP

Regulatory compliance

Documentation

Risk-based monitoring

Communication

Teamwork/independence

MS Office

Education

Bachelor's degree in life sciences or RN

Tools

Microsoft Office

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as an FSP Clinical Research Associate (Level I & Level II) - 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.

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 6 months minimum of travel monitoring is required)

Therapeutic areas preferred-> Oncology - Respiratory (COPD, asthma, nasal polyps, etc.) & Cardiovascular.

Valid driver's license where applicable.

Candidates must live within 60 miles of the nearest major airport. 60- 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
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Ability to remain flexible and adaptable in a wide range of scenarios
• Ability to work in a team or independently as required
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate 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 drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Personal protective equipment required such as 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 Florida is $75,000.00-$115,000.00.

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:

• 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.