Main Objective:
To facilitate clinical research activities.
Essential Duties and Responsibilities:
· Overseeing the smooth running of clinical trials.
· Collecting, coding, and analyzing data obtained from research.
· Informing participants about study objectives.
· Administering questionnaires.
· Monitoring research participants to ensure adherence to study rules.
· Adhering to research regulatory standards.
· Adhering to ethical standards.
· Maintaining detailed records of studies as per FDA guidelines, including things such as drug dispensation.
· Liaising with laboratories regarding findings.
· Participating in subject recruitment efforts.
· Ensuring that the necessary supplies and equipment for a study are in stock and in working order.
· Engaging with subjects and understanding their concerns.
· Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
· Assists PI in communication of study requirements to all individuals involved in the study.
· Works with the PI to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.
· Conducts or participates in the informed consent process including interactions with the HRPO (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
· Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
· Registers participants to the appropriate coordinating center (if multi-site study).
· Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
· Coordinates participant tests and procedures including blood draws
· Collects data as required by the protocol. Assures timely completion of Case Report Forms.
· Maintains study timelines.
· Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or ARHI Policy on Investigational Drug/Device Accountability.
· Completes study documentation and maintains study files in accordance with sponsor requirements and ARHI policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
· Retains all study records in accordance with sponsor requirements and university policies and procedures.
· Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
· Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management
Incidental Duties:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Reports to: Lead Clinical Research Coordinator
Requirement: Phlebotomy Training. Will consider phlebotomy techs willing to become Clinical Research Coordinators.
Job Type: Full-time
Base Pay: $18.00 - $22.00 per hour
Benefits:
- Paid time off
- Referral program
Application Question(s):
- Do you have phlebotomy training? (Required)
Language:
- English/Spanish (Required)
Location:
- Naples, FL 34102 (Preferred)
Ability to Commute:
- Naples, FL 34102 (Required)
Work Location: In person
