Clinical Research Coordinator II, Early Phase Clinical Research Dallas, TX

Join our clinical operations team and help ensure highquality execution of earlyphase clinical studies. As a Clinical Research Coordinator II youll support study planning oversee daily trial activities and maintain participant safety while serving as a key point of contact for the Project Manager and site teams.

What Youll Do

• Lead study startup activities including developing study documents schedules and procedure plans.

• Coordinate daily study conduct including checkins dosing days and participant flow.

• Monitor participant safety compliance and wellbeing; escalate issues as needed.

• Participate in planning meetings and support client visits calls and audits.

• Review protocols provide site feedback and distribute final versions.

• Maintain study master files and ensure documents are ready for eTMF upload.

• Manage sample shipping schedules and ensure timely dispatch of biological samples.

• Support monitoring visits resolve data queries and assist with source documentation.

• Contribute to recruitment planning and updating the PM on enrollment progress.

• Deliver studyspecific training and help mentor junior staff.

• Verify participant eligibility at screening and predose.

• Approve participant stipend payments and handle participant feedback.

What You Bring

• High school diploma or equivalent (degree in life sciences or allied health preferred).

• 34 years of experience in a clinical research environment.

• Strong knowledge of protocols ICHGCP and study procedures.

• Excellent communication organization and prioritization skills.

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 ERGs (employee resource groups)

• Experience coordinating people or processes; customerservice experience helpful.

Learn more about our EEO & Accommodations request here.