- One to two years experience as a certified research coordinator required.
Will be responsible for conducting clinical trials in the clinic and with Fresenius at the dialysis units.
- Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
- Conducts or participates in the informed consent process 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.
- Coordinate participant visit schedule and complete study visits as outlined in specific protocols.
- Enter data collected for study visits into study specific EDC – ensuring timely data entry and resolving queries.
- Ensure study stipends are distributed to subjects based on visit schedule.
- Responsible for report SAE’s and protocol deviations to sponsor.
- Identifies and screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
- Collects data as required by the protocol. Assures timely completion of Case Report Forms.
- Maintains study timelines.
- Maintains adequate inventory of study supplies (lab kits, shipping supplies, IP, etc.) to ensure availability for study visits. If handling investigational drugs/devices, follows the sponsor protocol.
- Completes study documentation and maintains study files in accordance with sponsor requirements and CAN/FMC policies and procedures including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational material accountability forms.
- Retains all study records in accordance with sponsor requirements.
- Maintains effective and ongoing communication with sponsor, research participants, dialysis staff, and PI during the course of the study.
- Develops visit worksheets (source documents) as necessary to ensure complete and accurate collection of data.
- Ensures adherence to Study Protocol, prevention of unauthorized protocol deviations, and compliance with FDA rules and guidelines for research studies.
- Ensures maintenance of accurate overall study drug accountability records (receipt, storage and dispensing).
- Ensure availability during site visits with study sponsor or CRO monitors.
- Ensures that discrepancies found by the monitors are corrected in a timely fashion.