CRF Specialist I (Part-time), Early Phase Clinical Research - Dallas, TX

We are currently seeking a CRF Specialist, to be responsible for transcribing and managing study data, ensuring accuracy, and collaborating with various stakeholders to meet project timelines and quality standards. 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 part-time, office-based position in Dallas, TX, working 20 hours per week. Scheduled shifts consist of 4-hour shifts on either first shift or mid-shift.

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 Specialists 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 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

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of clinical research.

Other key responsibilities:

• Transcribe and enter study data into case report forms using Metadata.

• Collaborate with quality control and project management teams to ensure timely completion.

• Address data questions and classifications during sponsor monitoring visits.

• Resolve sponsor-generated data queries promptly.

• Communicate effectively with data managers and CRAs, adhering to study protocols and SOPs.

• All other duties as needed or assigned.

YOU NEED TO BRING…

• High school diploma or equivalent.

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

• 1-2 years’ experience in a research environment or related experience.

• Strong attention to detail and accuracy.

• Excellent communication and organizational skills.

• Ability to work collaboratively with a team.

Experience in clinical research or related field is a plus.

Work Environment:

• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.

• Occasional drives to site locations, occasional domestic travel.

• Exposure to biological fluids.

• Personal protective equipment required such as protective eyewear, garments, and gloves.

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.

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)

• Experience coordinating people or processes; customer‑service experience helpful.