Job Details
Covenant Metabolic Specialists, LLC. is seeking a Clinical Research Coordinator to assist with our clinical operations by helping manage various clinical trials, ensuring site compliance, etc.
Covenant Metabolic Specialists (CMS) was founded in October of 2019 by a small group of medical professionals. This unique group of medical professionals offers an academic clinical setting for patients with various liver diseases along the west coast of Florida, with a primary focus towards fatty liver disease. Since the inception, CMS has emerged as a global leader in clinical management and education of fatty liver disease. With over 200 years of combined clinical experience and utilizing clinical treatments, which are not available outside of CMS, we are able offer healthcare to hundreds of patients. We look forward to offering leading state of the art clinical therapy and lifestyle guidance towards metabolic healthcare to the population in western Florida.
JOB DUTIES:
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 SOP s.
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 ensures compliance of all staff.
Provides accurately and timely data collection, documentation, and assists with EDC entry and queries.
Interfaces with research subjects to support efforts to determine eligibility and consenting of research subjects.
Ensures 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.
Monitors research subjects to ensure adherence to study protocol and reports deviations to the Sponsor and IRB as required.
Provides cross coverage for all studies as assigned by Chief Clinical Officer.
Collects and processes lab specimens, ECG s, vital signs, etc. as required per the study protocol.
Manages inventory of equipment and supplies related to study needs.
Schedules all subject visits and procedures consistent with the protocol requirements.
Reports SAE s and AE s 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 by the SubI/PI in a timely manner.
Meets with monitors during scheduled monitoring visits and close-out visits.
Attends weekly CRC meetings.
Attends SIV and IM meetings as required.
Attends end of day CRC Meetings for schedule planning
Reports all compliance issues to QC and Regulatory team
Complies with company Handbook guidance and rules
Collaborates and communicates with other team members as needed, i.e., recruitment, RA s, interns, PI/SubI.
Other duties as assigned
Language Proficiency:
Preferred: Proficiency in Spanish is preferred
Educational Requirements:
Required: Associate's Degree in a relevant field (such as Life Sciences, Nursing, Public Health, Healthcare Administration, etc.).
Preferred: Bachelor's degree or higher in a related field. Additional certifications related to clinical research (e.g., Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP)) are desirable.
Experience and Skills:
Experience: Minimum of 2 years of experience in clinical research coordination, including experience with regulatory compliance, patient interaction, and data management. Prior experience in gastroenterology research or a similar therapeutic area is a plus.
Regulatory Knowledge: Strong understanding of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, FDA regulations, and other regulatory requirements applicable to clinical research.
Technical Skills: Proficiency in using Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and Microsoft Office Suite.
Communication Skills: Excellent verbal and written communication skills to effectively engage with patients, staff, and sponsors.
Organizational Skills: Exceptional organizational and project management skills, with the ability to manage multiple trials and deadlines efficiently.
Certifications:
Required: Completion of CITI training (or equivalent) for human subjects research.
Preferred: Professional certification in clinical research (e.g., CCRC, CCRP).
Personal Qualities:
Detail-Oriented: Ability to manage complex documentation, ensure accuracy in data collection and reporting, and maintain meticulous records.
Problem-Solving Skills: Strong analytical and problem-solving skills to address challenges in clinical trial management and ensure protocol adherence.
Ethical Consideration: Commitment to upholding the highest standards of ethics and integrity in conducting research and ensuring patient safety and confidentiality.
Adaptability: Flexibility to adapt to changing protocols, study requirements, and work schedules as necessary.
Interpersonal Skills:
Strong interpersonal skills with the ability to work effectively both independently and as part of a multidisciplinary team. Ability to communicate effectively with diverse populations, including patients and research sponsors.
Salary Range: $60,000 - $90,000
Salary will be based on experience and education