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Clinical Research Coord III

Employer
University of Florida
Location
Main Campus (Gainesville, FL)

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Clinical Research Coord III

Job no: 514705
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Research/Scientific/Grants
Department:29050700 - MD-ENDOCRINOLOGY

Classification Title:

Clinical Research Coordinator III

Job Description:

1. IND (Investigational New Drug) Regulatory reporting and IND record maintenance
a. Assemble and submit IND amendments including annual reports, safety reports, and as needed amendments reflecting changes in accordance with all local, state, and federal laws
b. Participate in conference calls with contract research organizations as requested
c. Provide training to contract research organizations as needed
d. Facilitate regulatory monitoring performed by the UF-CTSI, and respond to queries as needed

2. Maintain Trial Master File (TMF)
a. Collaborate with clinical site investigators on local IRB submissions, and adding IRB approval documents to the TMF, including initial approval, revision approval, continuing review approval
b. Add essential documents to the TMF: Investigator and site qualification, financial disclosure attestation; clinical site protocol and revisions, clinical site informed consent and revisions, documentation of training

3. Provide clinical site and core site training for pivotal clinical trial
a. Complete site initiation training, protocol revision training, study medication training
b. Complete re-training as needed and if site non-compliance or site deviations occur

4. Study coordinator
a. Maintain IRB records for Sponsor-Investigator studies (pivotal clinical trial, open-label expanded access protocol, and registry studies
b. Assist local site investigator with study visits and documentation as needed
c. Data entry for enrolled subjects
5. Performs other duties as may be necessary, including travel to annual scientific meetings, with preparation of investigator meetings and delivery of research-related presentations

Expected Salary:

$48,000 - $66,000

Minimum Requirements:

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

Preferred Qualifications:Master’s degree preferred with 5+ years’ experience in coordinating clinical trials, experience with rare disease. Certified Clinical Research Coordinator with robust knowledge of research methods, policies, procedures, and regulatory requirements of GCP and FDA.Special Instructions to Applicants:Upload CV for consideration for this position.

This is a time-limited position.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required:Yes

Advertised: 22 Sep 2020 Eastern Daylight Time
Applications close: 09 Oct 2020 Eastern Daylight Time

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