Covenant Metabolic Specialists (CMS) is a leading medical practice dedicated to the clinical management and education of metabolic diseases, with a special focus on fatty liver disease and obesity. Founded in October 2019, CMS has rapidly emerged as a global leader in treating liver diseases through groundbreaking clinical care, research therapies and innovative treatments that are not available elsewhere. With over 200 years of combined clinical experience, our expert medical team delivers state-of-the-art therapies and lifestyle guidance to improve metabolic health for patients. Covenant is seeking a Clinical Research Coordinator for our facility located in the Fort Myers area. This position will assist with our clinical operations by helping manage various clinical trials, ensuring site compliance. A CRC Assessment will be required. Responsibilities Ensure site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities by following

GCP, ICH, FDA

Guidelines, and site SOPs. Complete and maintain CITI training. Ensure scientific integrity of data and protect rights, safety, and well-being of patients enrolled in clinical trials. Develop accurate source document materials and ensure compliance with all staff. Provide accurate and timely data collection, documentation, and assists with EDC entry and queries. Interface with research subjects to support efforts to determine eligibility and consenting of research subjects. Ensure compliance with research protocols by providing ongoing QC audits, maintaining IP drug accountability, accurate records of correspondence with Sponsors and patients, and following protocol specific guidelines. Monitor research subjects to ensure adherence to study protocol and reports deviations to the Sponsor and IRB as required. Provide cross coverage for all studies as assigned by Chief Clinical Officer. Collect and process lab specimens, ECG's, vital signs, etc. as required per the study protocol. Manage inventory of equipment and supplies related to study needs. Schedule all subject visits and procedures consistent with the protocol requirements. Reports SAEs and AEs in the timeframe required by the Sponsor and IRB and collaborates with the PI/SubI on assessing the AE relationship/causality. Monitors laboratory and other imaging reports for any abnormalities that need to be addressed in a timely manner by the SubI/PI. Meet with monitors during scheduled monitoring visits and close-out visits. Attend weekly CRC meetings. Attend SIV and IM meetings as required. Attend end of day CRC Meetings for schedule planning Report all compliance issues to QC and Regulatory team. Comply with company Handbook guidance and rules. Collaborate and communicate with other team members as needed, i.e., recruitment, interns, PI/SubI. Other duties as assigned. Education and Experience Associate's Degree required; BS preferred. CRC certification preferred. Four years' experience at clinical trials site. Prior experience in a healthcare setting. Other Skills and Abilities Exceptional attention to detail. Excellent communications skills (interpersonal, written, verbal). Strong organizational skills to effectively managing multiple tasks and deadlines. Ability to work well with patients and team members. Possess good problem-solving skills with the ability to identify and resolve issues. Ability to read, analyze and interpret complex documents. Covenant Metabolic Specialists, LLC is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status, or any other characteristic protected by law.

Job Type:

Full-time Pay:

$60,000.00 - $90,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance

Education:

Associate (Required)

Experience:

clinical trials: 4 years (Required)

License/Certification:

CRC Certification (Preferred)

Work Location:

In person