FSP CRA I West & Central

Work Schedule

Environmental Conditions

Job Description

Join Us as an FSP Clinical Research Associate (Level I) Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech spanning 2700 clinical trials across 100 countries in the last five years.

As part of our global team youll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II) youll 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 youll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II) youll 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:

Bachelors 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 study coordinator CTC RN MD or similar clinical role is required)

Valid drivers license where applicable.

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
Well-developed critical thinking skills including but not limited to: critical mindset in-depthinvestigation 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 flexibile 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

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: