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