Clinical Research Coordinator I

University of Central Florida•Orlando, FL

3d•$56,030 - $68,637

About The Position

The University of Central Florida College of Medicine seeks an experienced clinical research professional to provide expert support to the Manager-Clinical Trials across business development, study start-up, quality assurance, study operations, and study closure. The coordinator supports clinical research projects and clinical trials from initial opportunity identification and feasibility through activation, conduct, and close-out, working with sponsors, institutional units, investigators, vendors, participants, and other stakeholders. The role includes regulatory and financial administration, study coordination, and quality oversight. The coordinator prepares and maintains regulatory submissions and study records, supports budgets and study accounts, coordinates equipment and vendors, and performs participant-facing activities and data entry as needed. The position also supports monitoring and audit visits, trains and guides research staff on quality, and may serve as a delegate for the manager on business processes and time-sheet approvals. Other duties and administrative responsibilities are assigned by the Clinical Research Manager or study principal investigator.

Requirements

Bachelor’s or master’s degree and at least 2 years of relevant experience, or an equivalent combination of education and experience pursuant to Fla. Stat. 112.219(6).
Valid Class E driver’s license.
Authorization to work for any U.S. employer; visa sponsorship and H-1B transfers or employment-based visa processing for individuals currently sponsored by another employer are not available.
Complete required university and college trainings and updates on time and maintain required training and certifications.

Nice To Haves

CCRP (Certified Clinical Research Professional, SOCRA) certification.
CCRC certification.
Certified Clinical Research Coordinator (ACRP) certification.
CTBS (Certified Tissue Bank Specialist, AATB) certification.
At least 2 years of clinical-trial experience.
Experience with data management.
Experience with patient care.

Responsibilities

Assist with business development by building relationships with industry sponsors, grantors, and funders, identifying opportunities, resolving issues with stakeholders, and communicating progress.
Work with sponsors, monitors, and auditors for site qualification, site initiation, and monitoring visits; participate in meetings, site visits, and special events.
Manage study start-up and close-out, advancing studies from intake and feasibility through budget, contract, regulatory and ancillary review, and activation in coordination with institutional units and partners.
Prepare initial and ongoing UCF IRB, central IRB, FDA, and ClinicalTrials.gov applications, as well as other internal regulatory applications and reports; perform required regulatory reporting and advise College of Medicine faculty and staff on regulatory requirements.
Prepare studies for privacy officer review.
Support clinical research finance functions, including formulating budgets, assessing inventory, requesting procurements, overseeing gift cards and study accounts, and coordinating vendor set-up and ongoing service.
Accept and return equipment and ensure clinical trial equipment is present and calibrated.
Perform study coordination as needed, including marketing studies, informed consent sessions, study data collection, participant communications, scheduling study visits, and data entry into electronic medical records.
Maintain accurate and current information in the electronic regulatory system and enter de-identified information into electronic case report forms.
Follow state and federal regulations, protocol requirements, and Good Clinical Practice Guidelines.
Collaborate with investigators, sub-investigators, referring physicians, patients and their families, and other research staff; serve as a clinical research resource for internal and external stakeholders and the community.
Review studies for quality and ensure protocol compliance; review case report forms and audit them for accuracy against source documents.
Prepare for internal and external monitoring and audit visits, including FDA audits, and attend sponsor site-monitoring meetings.
Provide quality training and guidance to other research staff; complete adverse-event and protocol-deviation reporting.
Serve as the manager’s delegate for business processes and time-sheet approvals during the manager’s absence.
Manage short-term business-related projects.
Maintain required training and certifications, attend assigned meetings, complete university and college trainings and updates on time, and perform other duties assigned by the Clinical Research Manager or study principal investigator.