OPS Clinical Research Coordinator - Vascular Surgery

Vascular Surgery•Gainesville, FL

15h•Onsite

About The Position

This role involves the coordination of clinical research protocols, focusing on subject management, data collection, and ensuring compliance with all relevant guidelines and regulations. The coordinator will serve as a key point of contact for patients, healthcare providers, and regulatory bodies, supporting the design, execution, and reporting of research studies within Vascular Surgery.

Requirements

Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.

Nice To Haves

Excellent communication skills; must be able to communicate with patients and family participating in clinical trials.
Experience as research coordinator preferred.
Experience with patient data and/or databases.
Proficient time management skills and ability to successfully manage multiple studies.

Responsibilities

Performs subject screening and consent for clinical protocols under direction of Principal Investigator.
Serves as patient resource and educator for information regarding the study or clinical symptoms.
Prepares and ships central laboratory samples as per protocol requirements.
Collects baseline and follow-up data from the medical record.
Documents findings in appropriate source records and case report forms.
Schedules and attends clinic appointments for patients as required by protocol.
Communicates with nursing staff and OR Staff about patient care according to protocols.
Assists with operating room protocol requirements where appropriate.
Records patient symptoms and adverse events in conjunction with care providers.
Reports and follows up adverse events and serious adverse events, after discussion with Principal Investigator, to sponsor and Investigational Review Board as required by protocol.
Maintains knowledge base of Good Clinical Practice Guidelines and Federal Code of Regulations regarding clinical trial conduct.
Coordinates and maintains HIPAA compliance for assigned studies.
Communicates with interdisciplinary health team in care of patients involved in research studies to ensure regulatory compliance.
Interacts with local laboratories and diagnostic study centers to ensure clinical protocol requirements are complete for studies.
Coordinates efforts of Investigational Pharmacist and maintains site records for Good Clinical Practice and sponsor guidelines.
Assists medical and scientific partners to design protocol methodologies for basic science, preclinical studies, and clinical protocols.
Helps with protocol development and protocol endpoints to ensure statistical and clinical relevance of studies.
Assesses clinical needs by performing literature review and discussion with faculty advisors within Division.
Prepares and submits filings of protocols to Investigational Review Board and Animal Care Committees as needed.
Designs Case Report Forms and Source Documents for clinical protocols where required.
Assists with grant development projects.
Maintains awareness of Good Laboratory Practices as needed for preclinical studies within Division.
Assists with manuscript preparation and abstract submission for principal investigators.
Submits protocols to the RAC and IRB offices to assure compliance under the direction of the senior study coordinator.
Organizes and maintains regulatory files for clinical studies performed within Division.
Interacts with institutional Investigational Review Board under direction of Principal Investigator for clinical research protocols.
Tracks the type of study services performed to ensure that they are compensated appropriately.
Performs billing review for study subjects.
Dispense human subjects’ payments to study participants.