Case Report Form Specialist I

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Case Report Form Specialist I

As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US.

We are currently seeking a Case Report Form Specialist, to lead and support our Clinical Pharmacology Start-up team in initiating Early Phase clinical trials for our clients with maximum speed and efficiency.

This is a full-time, office-based position in our Daytona Beach, FL Clinic

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

Many Technicians are drawn to their profession because of its direct impact on patient care. If this is your case, you will not miss that working in Phase 1 trials. Whilst allowing you to have a close face-to-face relationship with participants, and as you continue to practice your clinical skills and knowledge, youll be involved with the latest medical technologies and treatments, witnessing their development firsthand. When the drug you worked with gets approved, you know youll touch many patients lives around the world.

What You Will Do

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

Summary of Responsibilities:

• Transcribe study data into case report form
• Enter data into the computer using the currently defined data management software.
• Work in conjunction with quality control and project manager to ensure that case report form completion timelines are met.
• Work with sponsors during monitoring visits to ensure all data questions and clarifications are answered.
• Responsible for creation and maintenance of data entry spreadsheets
• Timely follow-up and resolution to all sponsor generated data queries
• Constantly look for ways to improve the efficiency and quality of unit work processes.
• Perform other related duties as assigned.

Qualifications (Minimum Required):

• High School Diploma or equivalent
• Language Skills Required:
  • Speaking: Yes, English
  • Writing/Reading: Yes, English
• Competencies:
  • Focus on the Customer
  • Innovate and Change
  • Pursue Scientific and Process Excellence
  • Work with Others
  • Achieve Results

Experience (Minimum Required):

• 1-2 years of related experience.
• Previous clinical experience is ideal, but not a must. We are open to consider recent graduates or any recent clinical experience.

Physical Demands / Work Environment:

• Regularly required to sit.
• Must have excellent command of the English language, both oral and written.
• Must be able to use hands to finger, handle, or touch objects, tools or controls, including a computer keyboard, for up to 6 hours per day.
• Must be able to lift and/or move up to 40 pounds on a daily basis.
• Should be able to change focus easily to meet the next deadline and if necessary, pick-up with previous project as time allows.
• Overtime and weekend work as required.

The important thing for us is you are comfortable working in an environment that is:

• Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
• Changing priorities constantly asking you to prioritize and adapt on the spot.
• Teamwork and people skills are essential for the study to run smoothly.
• Technology based. We collect our data directly into an electronic environment.

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)

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see ourPrivacy Statement.