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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 Beside Data Capture Operations Specialist, to interact directly with our healthy volunteer participants while learning to read clinical research protocols and enjoy working in a fast-paced team-oriented environment. Each day is different, you will be exposed to a wide variety of Therapeutic Indications and study types (ascending dose, first-in-human, food effect, drug to drug interactions, etc.)
This is a full-time, office/clinic-based job in Daytona Beach, FL.
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.
Many 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, you´ll be involved with the latest medical technologies and treatments, witnessing their development firsthand. When the drug you worked with gets approved, you know you´ll touch many patient´s lives around the world.
WHAT YOU WILL DO:
Responsible for overseeing the Bedside Data Capture (BDC) quality review process and serving as the site BDC administrator. This role ensures all subject appointment, recruitment, and activity status data are accurately maintained and aligned with established processes, procedures, and SOPs.
Other key responsibilities:
Serve as an SME for all BDC-related activities.
Participate in key study planning meetings, including BDC Build Kick-Off Meetings, Clinic Start-Up Meetings, Clinical Planning Meetings, and Site Initiation Meetings, as required.
Perform regular reviews of collected BDC data; issue and resolve study data queries (SDQFs) in a timely manner.
Review and interpret Study Completion Guidelines (SCGs) for all active studies.
Monitor and update subject status regularly to ensure data accuracy.
Track and document study build review participation at the site level, including forms, activity plans, cohort structures, sample paths, and lab panels.
Consolidate and prepare study build review feedback prior to build meetings.
Assist with onboarding and continuous training of operational staff on BDC system use.
Serve as the point of contact for cohort assignment updates, including creating new cohorts, updating activity plans, and disabling unused plans.
Support lab personnel in the setup and organization of sample packaging containers.
Maintain a working knowledge of routine and specialized study procedure forms.
Develop a deep understanding of BDC system user roles and their permissions.
Understand and support data collection logistics within the Clinical Research Unit (CRU).
Act as a subject matter expert for all BDC system modules.
YOU NEED TO BRING…
Bachelor’s degree preferred (in life sciences, pharmacy, or a related field), or certification in a relevant allied health profession (e.g., nursing, medical/lab technology).
At least 1 year of experience in a clinical research environment.
Hands-on experience using the Bedside Data Capture (BDC) system.
Proficient in Microsoft Office, especially Excel.
Strong general computer skills with proficiency in various software applications.
Excellent written and verbal communication skills.
Strong organizational skills with the ability to prioritize tasks effectively.
Equivalent relevant experience may be considered in lieu of formal education.
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 a 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)
Physical Requirements:
Ability to work in an upright and /or stationary position for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Regular and consistent attendance.
Varied hours may be required.
Learn more about our EEO & Accommodations request here.
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