Clinical Research Coord II
Job no: 516498
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Department:29050300 - MD-RHEUMATOLOGY
Clinical Research Coordinator IIJob Description:
The Department of Medicine, Division of Rheumatology is seeking a full time Clinical Research Coordinator II. This position will be involved with the research efforts of Dr. Michael Bubb. Dr. Bubb’s research focuses on osteoarthritis, rheumatoid arthritis, and systemic lupus erythematosus. Associated responsibilities for this position include, but are not limited to: (1) Manage study finances including sponsor invoicing & resolving study subject billing issues; (2) Participate in the development and conduct of study billing plans; (3) Develop advertisement materials; (4) Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals; (5) Document investigational product (drug/device) accountability; (6) Self-monitor and self-audit responsibilities; (7) Develop informed consent document; (8) Register and maintain study in Clinical Trial.gov; (9) Develop Case Report Forms; (10) Participates in promoting Human Subjects Protections within Clinical Research areas.
Review and follow research protocols to screen and enroll patients into IRB approved studies:
Acts as a liaison for research subject, investigator, IRB, sponsor, and healthcare professionals who are part of the research or patient care team for smooth and informed implementation of studies.
Coordination of relevant care for research participants according to protocol-specified procedures, including scheduling and execution of study visits and other study-related procedures.
Accurate and timely data collection, documentation, data entry, and data reporting in both sponsor and UF databases.
Document investigational product (drug/device) accountability
Use of EPIC to enter procedure orders and route to providers for signature, prescreening clinic lists for eligible study participants, and chart reviews of clinical data.
Communicate serious adverse events and both planned and unplanned subject deviations to the IRB, sponsor, and/or FDA according to established reporting requirements.
Responsible for implementing good clinical practice (GCP) and follows the Code of Federal Regulations (CFR) and Health Insurance Portability and Accountability Act (HIPAA), and follows the University of Florida policies and procedures and research related protocols.
Creation and development of study materials, including but not limited to study advertisement materials, informed consent forms (ICFs), case report forms (CRFs), and other source documentation as necessary.
Registration and maintenance of studies in Clinical Trial.gov database.
Maintenance of regulatory files in accordance with GCP guidelines.
Collaboration with external study monitors and/or with sponsors’ data management units to resolve case report form discrepancies.
Answer data queries, monitor for data delinquencies, and replies to special requests as necessary.
Participation in internal and external inspections and audits of subject medical records to ensure compliance with the protocol.
Ensures that regulatory documents are properly filed in regulatory study binders and that regulatory binders are up to date for review by auditors and study monitors.
Study start-up and close-out processes (i.e.; protocol review and feasibility, submission of OCR intake, completion and distribution of initial and final regulatory documents, reconciliation of study data in OnCore.)
Preparation and submission of initial review to IRB as a part of study start-up process.
Submit continuing review/study closure reports, serious adverse event reports, protocol revisions and other documents to the IRB within appropriate timelines to prevent project expiration or sponsor deficiencies.
Preparation of cumulative adverse event tables and deviation reports as required for continuing review or closure reports.
Review of all finalized IRB submissions packets for accuracy and completeness prior to submission, and tracking all submissions to their final status to verify completion.
Ensures that all approval documents are distributed and filed in regulatory and/or study binders.
Assists in developing study checklists, completing source document data and case report forms. Enters data into appropriate study databases and develops databases as needed. Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and UF databases.Expected Salary:
$44,700 - $50,000Minimum Requirements:
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.Preferred Qualifications:
Special Instructions to Applicants:
In order to be considered, you must upload your resume.
The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.Health Assessment Required:
Advertised: 28 Apr 2021 Eastern Daylight Time
Applications close: 06 May 2021 Eastern Daylight Time