Clinical Research Coordinator II

Intercoastal-Medical-Group; Sarasota (FL); On-site; USD 60,000 - 75,000; Full time

Job summary

Intercoastal Medical Group seeks a Clinical Research Coordinator II to manage day-to-day clinical trial activities in a healthcare setting. You will coordinate participant recruitment, consent processes, data collection, and regulatory compliance to ensure study integrity.

Responsibilities include collaboration with investigators, sponsors, and staff, as well as monitoring safety, maintaining documentation, and supporting quality improvement initiatives across studies.

Qualifications

• High School Diploma or Equivalent is required.
• Accredited Medical Assistant Program or Licensed Practical Nurse or Registered Nurse program completed.
• At least 3 years coordinating clinical research studies in healthcare/academic settings.
• Knowledge of FDA, IRB, and GCP regulations.
• Strong organizational and multi-study management abilities.
• Proficiency with electronic data capture systems and MS Office Suite.

Responsibilities

• Coordinate day-to-day activities of clinical research studies.
• Ensure compliance with study protocols, GCP, FDA and IRB guidelines.
• Maintain accurate study documentation (CRFs, regulatory binders, EDC).
• Collaborate with investigators, staff and sponsors to progress studies.
• Monitor participant safety and report adverse events per protocol.
• Schedule visits, collect samples, and perform required procedures.
• Assist in regulatory document preparation and submission.
• Train and mentor junior staff and support quality improvements.

Education

High School Diploma or Equivalent

Accredited Medical Assistant Program or Licensed Practical Nurse Program or Registered Nurse Program

3+ years coordinating clinical research studies

FDA/IRB/GCP knowledge

Strong organizational skills

Proficiency with electronic data capture systems

Microsoft Office Suite proficiency

Interpersonal and communication skills

Tools

Electronic Data Capture (EDC) systems

Microsoft Office

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Clinical Research Coordinator II

Sarasota, FL, US

11 days ago Requisition ID: 1135

About Company:

Founded in 1993, Intercoastal Medical Group is an association of more than 100 highly credentialed physicians encompassing many medical specialties serving Sarasota County and Manatee County, Florida with nine locations. Intercoastal is the premier provider of choice in the Sarasota / Bradenton area.

Intercoastal Medical Group also prides itself on offering this area’s most current technology and resources. Extensive laboratory and diagnostic equipment and a day surgery center allow for fast and accurate diagnostic tests and procedures at conveniently located Intercoastal facilities.

We are always looking for qualified and compassionate professionals to join our team of dedicated providers and staff. If you enjoy working in a fast-paced environment where you can truly make a difference in the lives of patients, then Intercoastal Medical Group is the place for you.

About the Role:

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.

Salary will commensurate with research experience and certifications.

Minimum Qualifications:

• 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.

Preferred Qualifications:

• 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.

Skills:

The Clinical Research Coordinator II utilizes 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. Additionally, problem-solving abilities are essential to address challenges that arise during study conduct and to implement process improvements.

*Intercoastal is a drug free workplace and EEO compliant.