Offer summary

Qualifications:

At least 4 to 5 years of experience in a clinical research environment, particularly in Phase I studies., University/College Degree in a technical or Life Sciences focus area, or equivalent experience in clinical research., Strong understanding of Electronic Data Capture (EDC) and clinical trial processes, including 21 CFR Part 11 compliance., Proficient in MS Office, especially Excel and Word, with good computer skills and knowledge of medical terminology..

Key responsibilities:

Create studies and components within the Bedside Data Capture (BDC) system based on study protocols and timelines.

Configure studies within the electronic data capture system, including recruitment and screening components.

Maintain study documents and ensure all required documents are available for the electronic trial master file (eTMF).

Serve as a point of contact for other departments and support internal and external audit initiatives.

Job description

A career in Clinical Research with Fortrea: from the hospital ward to the world.

If you join us, you will work with some of the world´s leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug.

We are currently seeking a Study Designer I, to work in close conjunction with other BDC staff, Project Managers, Clinic Study Teams, Biometrics, CRAs, IT Staff and the IT Help Desk. The Study Designer will communicate and collaborate with internal and external teams to meet study timelines and be responsible to maintain an understanding of applicable regulatory requirements overall.

This is a full-time, remote based position in the US.

*Preferred candidates will close to one of our sites in Madison, Wi – Dallas, TX – or Daytona Beach, Florida.*

WHAT YOU WILL DO

You will be responsible for the creation of studies and all require components within the Bedside Data Capture (BDC) system based on the study protocol and timelines.

Other key responsibilities:

Perform any post go-live updates within the BDC system.
Effectively configure studies within the electronic data capture system, including recruitment, screening, and on-study components.
Assignment to complex studies / projects or ownership of a portfolio of studies.
Understands electronic data capture system and connection to electronic case report form (eCRF).
Read and understand study protocols and Fortrea SOPs as background to enable accurate translation of the study design into data collection forms containing both CRF and non-CRF fields within the electronic data capture system.
Provide data and expertise as required to support internal and external requests including audit initiatives.
Support maintenance of study documents ensuring all required documents are available for uploading to the electronic trial master file (eTMF).
Serves as a CLIN Spark point of contact for other Fortrea departments.
Work with the Supervisor/Manager to ensure that all processes are regularly reviewed to maintain best working practices.
Undertake any other duties as required

YOU NEED TO BRING…

At least 4 to 5 years of experience working in a clinical research environment with an emphasis in Phase I.
Understanding of Electronic Data Capture (EDC) and the clinical trial process.
Experience interpreting Clinical Study Protocols.
Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO or related industry.
Strong MS / Office skills with Excel and Word.
Knowledge of medical terminology preferred.
Prior experience performing complex technical activities.
Good computer skills with good working knowledge of a range of software packages.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
University/College Degree (preferably a bachelor's degree) in a technical or Life Sciences focus area.
Equivalent experience within clinical research environment of 5+ years may be substituted for education requirements.
Technical understanding and working knowledge of electronic data capture software applications.
Technical understanding and working knowledge of clinical protocol source data documentation.
Understanding simple logic, links code, and algebra.
Knowledge of end-to-end clinical trial management.
Specific skills, systems, certifications, and/or licenses necessary
Fluent in English, both written and verbal.

What do you get?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
401(K)
Paid time off (PTO)
Employee recognition awards
Multiple ERG’s (employee resource groups)

Pay Range: $65,000- $92,000/annually

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.

Application Deadline: June 9, 2025

#LI-REMOTE

#LI-SE1

Learn more about our EEO & Accommodations request here.

Required profile