Study Report Data Specialist - Part Time / Daytona Beach, FL (On-Site)

You will utilize your skills, knowledge, and clinical judgement for all aspects of data capture, review and quality for Phase I studies. The Clinical Data Monitor I is someone who ensures that all data and information is produced on time, in accordance with defined quality standards and meets the requirements of the business and our customers., * Transcribe study data into case report form

• Enter data into the computer using the currently defined data management software.
• Work in conjunction with study coordinators, quality, 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.
• 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.
• And perform other related duties as assigned.

• High School Diploma or equivalent
• 1-2 years experience specific to CRF data and case reporting, industry experience, sponsor experience
• Clinical Research experience is preferred

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., * 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.

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)

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 Study Report Data Specialist / Part-Time, 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 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 are drawn to this 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.