Clinical Data Monitor, Phase I - Early Phase Clinical Research - Dallas, TX

The Clinical Data Monitor supports core clinical data management activities by ensuring accuracy, completeness, and regulatory compliance throughout the study lifecycle. This role is key in maintaining study documentation, performing accurate data entry, and assisting with operational tasks across multiple projects.

In this position, you will contribute to early‑phase clinical trials that evaluate the safety and pharmacokinetics of investigational drugs. You’ll collaborate with teams conducting studies for leading pharmaceutical, biotechnology, and medical device companies, gaining valuable exposure to new therapies and emerging medical technologies.

What You'll Do

• Follow project guidelines for scanning, indexing, data entry, tracking, and administrative tasks

• Scan, index, and manage study documents, including CRFs and essential records

• Enter and verify clinical data with high accuracy

• Assist with EDC account setup, updates, and deactivations

• Support decommissioning activities (PDF/media QC, shipment prep, and tracking)

• Maintain project files in eTMF/TMF per SOPs, GCP, and ICH requirements

• Perform archiving duties for paper and electronic records

• Complete additional tasks as needed to support study operations

What You Bring

• Bachelor’s degree in Life Sciences, Pharmacy, or related field preferred

• Relevant experience may be considered in lieu of degree

• 1–2 years of experience in a research environment or related setting

• Strong attention to detail and accuracy

• Effective communication and organizational skills

• Ability to work collaboratively within a team

• Experience in clinical research 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.