Clinical Research Coordinator II

INTERCOASTAL MEDICAL GROUP• Sarasota, FL, US, FL

3d•Onsite

About The Position

The Clinical Research Coordinator II plays a pivotal role in the successful execution and management of clinical research studies within healthcare settings. This position is responsible for coordinating all aspects of clinical trials, ensuring compliance with regulatory requirements, and maintaining the integrity and accuracy of study data. The coordinator will serve as a liaison between investigators, study participants, sponsors, and regulatory bodies to facilitate smooth study operations. They will oversee participant recruitment, informed consent processes, and data collection while monitoring adherence to study protocols. Ultimately, this role contributes to advancing medical knowledge and improving patient care through rigorous clinical research.

Requirements

High School Diploma or Equivalent.
Successful completion of an accredited medical assistant program. licensed practical nurse program or registered nurse program.
At least 3 years of experience coordinating clinical research studies in a healthcare or academic setting as a Clinical Research Coordinator II.
Knowledge of clinical research regulations, including FDA, IRB, and GCP guidelines.
Strong organizational skills with the ability to manage multiple studies simultaneously.
Proficiency in electronic data capture systems and Microsoft Office Suite.
Strong organizational and communication skills daily to manage complex clinical trial logistics and ensure protocol adherence.
Attention to detail is critical when maintaining accurate study documentation and handling regulatory submissions.
Proficiency with electronic data capture systems and Microsoft Office tools supports efficient data management and reporting.
Interpersonal skills enable effective collaboration with investigators, participants, and sponsors, fostering a cooperative research environment.
Problem-solving abilities are essential to address challenges that arise during study conduct and to implement process improvements.

Nice To Haves

Bachelor’s degree or higher in a health-related field
Certification as a Clinical Research Coordinator (CCRC) by ACRP within the first year of employment
Current state licensure as a Licensed Practical Nurse or Registered Nurse; or current medical assistant certification
Experience with neurology or other specialized therapeutic area clinical trials.
Familiarity with statistical software and data analysis techniques.
Demonstrated ability to work effectively in multidisciplinary teams and communicate with diverse stakeholders.

Responsibilities

Coordinate and manage day-to-day activities of clinical research studies, including participant recruitment, screening, enrollment, and follow-up.
Ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements such as FDA and IRB guidelines.
Maintain accurate and detailed study documentation, including case report forms, regulatory binders, and electronic data capture systems.
Collaborate with principal investigators, research staff, and external sponsors to facilitate study progress and resolve any issues.
Monitor participant safety and report adverse events promptly according to protocol and regulatory standards.
Schedule and conduct study visits, collect biological samples, and administer study-related procedures as required.
Assist in the preparation and submission of regulatory documents and study reports.
Train and mentor junior research staff and support continuous quality improvement initiatives within the research team.