Clinical Data Monitor, Phase I Dallas, TX

Dallas, IA - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

As one of the largest Clinical Research Organizations globally we operate Early Phase Clinical Research Units in both the United States and the United Kingdom. We are currently seeking a Clinical Data Monitor to join our Dallas TX team in a fulltime officebased role.

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 earlyphase clinical trials that evaluate the safety and pharmacokinetics of investigational drugs. Youll collaborate with teams conducting studies for leading pharmaceutical biotechnology and medical device companies gaining valuable exposure to new therapies and emerging medical technologies.

What Youll 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

Bachelors degree in Life Sciences Pharmacy or related field preferred
Relevant experience may be considered in lieu of degree
12 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 ERGs (employee resource groups)
Experience coordinating people or processes; customerservice experience helpful.

Learn more about our EEO & Accommodations request here.

As one of the largest Clinical Research Organizations globally we operate Early Phase Clinical Research Units in both the United States and the United Kingdom. We are currently seeking a Clinical Data Monitor to join our Dallas TX team in a fulltime officebased role.The Clinical Data Monitor support...