Operations Coordinator I Early Phase Clinical Research Dallas, TX

As one of the largest Clinical Research Organizations in the world we have four Early Phase Clinical Research Units in the UK and US.

This is a full-time office-based position in Dallas TX.

Key responsibilities:

• Support study startup logistics and daytoday trial operations.

• Assist and back up the Clinical Research Coordinator as needed.

• Create and maintain study documents schedules labels and instructions.

• Coordinate supplies equipment lab services and sample shipments.

• Support staff training on studyspecific procedures.

• Assist with participant checkin discharge and issue resolution.

• Compile data summaries CRFs deviations and reports.

• Ensure compliance with FDA GCP and ICH guidelines.

• Maintain accurate records confidentiality and participant safety.

• Support SOP updates and train junior staff as needed.

• All other duties as needed or assigned.

YOU NEED TO BRING

• Bachelors degree in life sciences pharmacy or related field or equivalent experience.

• 12 years of professional experience with at least 1 year in clinical research preferred.

• CPR/BLS certification.

• Knowledge of clinical research processes GCP and ICH guidelines.

• Proficiency with Microsoft Word and Excel

• In lieu of a degree typically 2 years experience in a related field (e.g. pharmaceutical laboratory data analysis) will be considered in addition to the experience requirement.

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)

Learn more about our EEO & Accommodations request here.