Description

Clinical Research Regulatory and Operations Coordinator Investigator

Full-time, 40 hours, Monday - Friday, 8:30 am - 5:00 pm

Summary:

Reports to the VP, Research and Innovation. Collaborates with the research leadership, staff and investigators in the coordination of regulatory and operational aspects of investigator-initiated research (IIR) studies. Responsibilities include; all regulatory submissions, billing and invoicing, tracking Investigator Initiated Research tracking databases, tracking patient screening and recruitment, protocol implementation, and data tracking. Manages submissions to the Institutional Review Board (IRB) Performs additional non-clinical clinical research coordinator duties (eg data collection, obtaining informed consent) as necessary. Coordinates IIR studies in all therapeutic departments with the exception of the Cancer Center.

Responsibilities:

1. Collect, review and submit all documents required for initiating IIR Coordinate study start-up documentation requests in organized package and submit to the IRB.

2. Compile documents, including but not limited to, CVs, licenses, certificates, training logs, and financial disclosures, lab certifications (CLIA and CAP) for all study staff to be involved in IIR. Ensure all documentation for active studies remains current and file appropriately.

3. Support the daily operations of IIR by providing efficient administrative services including maintaining any IIR databases and study tracking spreadsheets and generation of departmental minutes and agendas.

4. For all studies requiring continuing review, ensure that all paperwork is submitted to the IRB in a timely fashion.

5. Handle invoicing, billing and tracking payments and revenue for internal and external stakeholders.

6. Attend onsite study initiation meetings with study teams.

7. Prepare regulatory documents, Safety reports, Serious Adverse event submissions and participates in internal and external regulatory quality assurance reviews and audits.

8. Serve as a research coordinator for departmental IIR research projects as required.

9. Ensures all documents remain up to date.

Other Information:

Qualifications:

Clinical Research Coordinator certification.

Required - Master's level education

Working Conditions:

Manual: Some manual skills/motor coord & finger dexterity

Occupational: Little or no potential for occupational risk

Physical Effort: Sedentary/light effort. May exert up to 10 lbs. force

Physical Environment: Generally pleasant working conditions

Company: Danbury Hospital

Org Unit: 326

Department: Clinical Research

Exempt: Yes

Salary Range: $31.25 - $58.05 Hourly, commensurate with experience

About Nuvance Health

Nuvance Health has a network of convenient hospital and outpatient locations — Danbury Hospital, New Milford Hospital, Norwalk Hospital and Sharon Hospital in Connecticut, and Northern Dutchess Hospital, Putnam Hospital Center and Vassar Brothers Medical Center in New York — plus multiple primary and specialty care physician practices locations, including The Heart Center, a leading provider of cardiology care. Non-acute care is offered through various affiliates.

EOE, including disability/vets.

We will endeavor to make a reasonable accommodation to the known physical or mental limitations of a qualified applicant with a disability unless the accommodation would impose an undue hardship on the operation of our business. If you believe you require such assistance to complete this form or to participate in an interview, please contact Human Resources at 203-739-7330 (for reasonable accommodation requests only). Please provide all information requested to assure that you are considered for current or future opportunities.

We are an equal opportunity employer

Qualified applicants are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender, national origin, age, genetic information, military or veteran status, sexual orientation, marital status or any other classification protected under applicable Federal, State or Local law.

We will endeavor to make a reasonable accommodation to the known physical or mental limitations of a qualified applicant with a disability unless the accommodation would impose an undue hardship on the operation or our business. If you believe you require such assistance to complete this form or to participate in an interview, please contact Human Resources at 203-739-7330 (for reasonable accommodation requests only). Please provide all information requested to ensure that you are considered for current or future opportunities.