Clinical Research Coordinator (Plano, TX)

Summary:
The Clinical Research Coordinator is a full-time, on-site role responsible for overseeing clinical research activities and ensuring the smooth execution of research studies. Key responsibilities include obtaining informed consent, managing clinical trial protocols, conducting research, and coordinating clinical trial processes. This position works closely with the clinical research team to maintain compliance with regulatory guidelines and deliver high-quality outcomes.
 

Responsibilities:

• Manage day-to-day clinical trial operations, including patient screening, enrollment, and follow-up.

• Ensure protocol compliance and maintain accurate study documentation.

• Coordinate with sponsors, contract research organizations (CROs), and study monitors.

• Conduct informed consent processes and patient visits.

• Manage regulatory documentation and site files.

• Handle data entry and query resolution.

• Assist with study startup and closeout activities.

• Collaborate with principal investigators and study staff.

• Maintain subject recruitment and retention strategies.

• Ensure compliance with protocol requirements and regulatory guidelines.

• Prepare for and participate in sponsor monitoring visits and audits.
   

Requirements:

• 3-5 years of experience in clinical research and clinical trials.

• Strong knowledge of ICH-GCP guidelines and FDA regulations.

• Hands-on experience with clinical trial management systems (CTMS), eSource, and EMR platforms.

• Proven skills in informed consent and protocol management.

• Excellent attention to detail and organizational abilities.

• Strong communication and interpersonal skills.

• Degree in Life Sciences, Nursing, or a related field.

• Experience in mental health studies is preferred.

Department: Direct Clients
This is a full time position