Clinical Research Coordinator

Company: CAN Community Health
Location: Sarasota
Posted on: May 3, 2024

Job Description:

Description:Job Title: Clinical Research Coordinator Date Prepared: 02/27/2017Status: Exempt EEO: Professional Date Revised: 01/12/2023 Statement of Purpose: The Clinical Research Coordinator (CRC) supports, facilitates, and coordinates the daily clinical trial activities under the direction of the Principal Investigator (PI). The CRC coordinates to support and complete the administration of the compliance, financial, personnel and other related aspects of the clinical study. Ensures that the best interests of all participants and the researchers are protected.Essential Functions:Coordinates with the PI, and the Director of Clinical Research (DCR); collaborating agencies, administration, and departments to help ensure that the clinical research and related activities are performed in accordance with Federal regulations and sponsoring agency policies and procedures. Collaborates with the PI and DCR to develop materials and tools necessary to appropriately train study participants in the conduct of the study around issues of protocol requirements, schedule of visits, and compliance. Ensures training is completed and documented according to all requirements Assists PI and DCR in the communication of study requirements and training compliance to all team members involved in conducting the study. Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion. Assesses, records and reports symptoms, reactions, treatments, and changes in clinical trial participant conditions.Performs EKG's, Venipunctures, Injections, infusions, and other procedures as required by the clinical research project. Register participants in the appropriate coordinating center and billing matrix as required. Coordinate participants tests and procedures. Collects data as required by the protocol. Maintains adequate inventory of study supplies. Cooperates with compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate venue. Reviews and develops a familiarity with the protocol, study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections. Coordinates and facilitates monitoring and auditing visits.Documents and reports all required information and submits all study materials according to policies and procedures set by the sponsoring agencies and company protocol. Establishes and organizes study files including regulatory binders, study specific source documentation and other materials. Assists the PI and DCR in study feasibility assessments as requested. Attends Clinical Research meetings as required or requested by the DCR. Prepares all study materials as requested by the PI including but not limited to informed consent documents, case report forms, enrollment logs, and drug/device accountability logs. Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research and adheres to all legal standards of professional practice. 20. Demonstrates courtesy, compassion, and respect in all interpersonal and intra-professional relationships with CAN clients, staff, visitors, and partners.21. Promotes and practices CAN Community Health Inc's mission and values and follows its policies and procedures.22. Ensures confidentiality is maintained by entire team regarding patient/client information in accordance with HIPAA, professional and departmental standards.23. Assisting nearby CAN clinics that are participating in trials.24. Maintain all Investigator site files, including licenses, CV, and training certificates.25. Submission of necessary documents to the IRB (initial applications, continuing review, deviations, communications etc.).Secondary Tasks:Triage patient phone calls and walk-ins and prioritizes emergencies for medical referral.Performs medical intake procedures including labs, vital signs and history.Participates in continuous quality improvement of services rendered to CAN clients.Develops and fosters networking relationships with community and support resources. Education/Professional:Minimum of a bachelor's degree, Life Sciences or in a health-related field. CPR CertifiedExperience:Minimum 3- years' experience directly related to the duties and responsibilities specified.Requirements:Competencies:LeadershipStrategic Thinking/Problem SolvingResults DrivenCommunicationInterpersonal SkillsDecision MakingComputer literate, ability to learn and utilize computer software programs.Knowledge, Skills and Abilities Required:Ability to work with minimal supervision.Ability to research projects.Excellent people manager, open to direction, suggestions, and commitment to get the job done.Delegates responsibility effectively.High comfort working in a diverse environment.CAN Required Trainings:Bloodborne Pathogen Annual TrainingHazardous Drug Disposal TrainingStericycle DOT Training Biohazard Waste TrainingHIPAAHIV/AIDSCITI Training (GCP, IATA)Compliance in Research TrainingSexual HarassmentViolence in the Workplace Health Stream Courses (as assigned) Work Environment:This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, audio visual, telephones, photocopiers, filing cabinets and fax machines. Physical Requirements:Neat, professional appearance.Sedentary- Exerts up to 25 lbs. of force occasionally and/or a negligible amount of force frequently or constantly in lift, carry, push, pull, or otherwise move objects. Involves sitting most of the time but may involve walking or standing for brief periods of time.Requires expressing or exchanging ideas by means of spoken word, visual and auditory acuity.Position Type/Expected Hours of Work:This position may require additional time above normal operating hours and on occasion weekend work.Travel:Travel is primary during the business day, although some out-of-area and overnight travel may be expected. Must be able to operate a motor vehicle and have valid insurance and driver's license.Other Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of an employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Responsible To: Director of Clinical Research & Chief Medical OfficerCAN Community Health is an equal opportunity employer that is committed to diversity and values the ways in which we are different. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristic protected by applicable law.PI090e2d55775e-25660-33973520

Keywords: CAN Community Health, Bradenton , Clinical Research Coordinator, Healthcare , Sarasota, Florida