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Coordinator, Clinical Research Program (George & Anne Ryan Institute for Neuroscience)

Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening.  To apply for the position, please click the Apply for this Job link/button.

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Please see Special Instructions for more details.

Please attach the following 2 (PDF) documents to your online Employment Application: (#1) Cover letter and (#2) Resume, which should include the names and contact information of three professional references.

Posting Details

Position Information

Posting Number SF00485
Job Title Coordinator, Clinical Research Program (George & Anne Ryan Institute for Neuroscience)
Position Number 108745
FTE 1.00
FLSA Exempt
Position Type Professional Staff
Union PSA/NEA - Professional Staff Assoc
Pay Grade Level 13
Pay Grade Range $66,259 - $83,641
Status Calendar Year, Full-time, Limited

Department Information

Department Ryan Institute for Neuroscience (GARIN)
Contact(s)

Gail Henriques
Faculty/Non-Classified Professional Staff Recruitment
Office of Human Resources
URI


(Please note: Applications must be submitted online only at: https://jobs.uri.edu)

Contact Phone/Extension
Contact Email
Physical Demands
Campus Location Kingston
Grant Funded
Extension Contingency Notes

Position is full-time calendar year, limited to 07-01-2020 with anticipated renewal.

Duties and Responsibilities

APPLICATION DEADLINE: This is an open until filled search. First consideration will be given to applications received by August 31, 2017. Second consideration may be given to applications received by September 29, 2017. Applications received subsequent to second consideration date (September 29, 2017) may not be given full consideration.
_________________________________________

BASIC FUNCTION:

Develop and coordinate the programmatic, administrative, and operational functions of clinical trial programs and related research and outreach. Act as primary liaison with investigative sites and contract research organizations (CROs). Assist in the preparation and submission of federal and local regulatory reports, both programmatic and budgetary. Assist in the daily operational and fiscal management of research and outreach projects within Rhode Island.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Assist the Executive Director, Associate Director, research grant administrators, and regulatory bodies in the preparation and submission of federal, state, and internal programmatic reports as directed, including but not limited to: IND and URI IRB submissions, local academic regulatory body submission support, and investigative site materials as needed (operations manual, study advertising, recruitment materials, data collection materials, study budget, etc.).

Coordinate clinical trial activities across investigative sites. Responsible for study start-up, regulatory submissions, investigative site audits, and clinical trial close-out activities. Serve as primary clinical trial contact for investigative sites in the day-to-day supervision of clinical trial operations/procedures, provide training to investigative site research staff, monitor staff performance and resulting data for quality control/assurance. Facilitate sponsor communications to investigative sites; actively participate in project meetings. Work with statistician to compile analytical reports in the appropriate format for federal submission.

Identify and coordinate agreements with CROs. Monitor and oversee CRO performance to ensure data quality and compliance with study scope and regulatory process.

Coordinate with Executive Director, Associate Director and principal investigators to meet reporting requirements, deadlines and approvals. Serve as primary point of contact for financial operations of clinical trial resources such as investigative site compensation for advertising and recruitment of study volunteers, data collection activities, local IRB submissions / support, and other research activities. Supervise clerical, student, and other support staff as required.

Maintain current with research methodological approaches, clinical operational techniques, and changes in U.S. FDA regulatory requirements and guidance through ongoing participation and membership in nationally recognized biopharmaceutical organizations.

LICENSES, TOOLS AND EQUIPMENT:

Personal computers and printers; word processing, database management and spreadsheet software.

Required Qualifications

REQUIRED:

1. Bachelor’s degree.

2. Minimum five years’ experience in clinical trial administration.

3. Demonstrated knowledge of U.S. FDA procedures.

4. Demonstrated ability to comply with regulatory reporting requirements and methods.

5. Demonstrated experience in a complex administrative support position with responsibility for operations related to the programmatic and financial management of clinical research programs.

6. Demonstrated experience with federal online reporting policies and procedures.

7. Demonstrated proficiency in computing (including word processing and database management).

8. Demonstrated proficiency in spreadsheet analysis and electronic mail systems.

9. Demonstrated supervisory experience.

10. Demonstrated strong interpersonal and verbal communication skills.

11. Demonstrated proficiency in written communication skills.

12. Demonstrated ability to work with diverse populations/groups.

Preferred Qualifications

PREFERRED:

1. Demonstrated ability to initiate, manage, and develop successful collaboration among academic, clinical, and government organizations.

2. Demonstrated attention to detail.

3. Demonstrated ability to prepare and deliver oral presentations.

Environmental Conditions

This position is not substantially exposed to adverse environmental conditions.

Posting Date 08/07/2017
Closing Date
Special Instructions to Applicants

Please attach the following 2 (PDF) documents to your online Employment Application: (#1) Cover letter and (#2) Resume, which should include the names and contact information of three professional references.

Quicklink for Posting http://jobs.uri.edu/postings/2625

Applicant Documents

Required Documents
  1. Cover Letter/Letter of Application
  2. Resume
Optional Documents

Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * Do you have a Bachelor’s degree?
    • Yes
    • No
  2. * Do you have a minimum five years’ experience in clinical trial administration?
    • Yes
    • No
  3. * Do you have demonstrated knowledge of U.S. FDA procedures?
    • Yes
    • No
  4. * Do you have demonstrated ability to comply with regulatory reporting requirements and methods?
    • Yes
    • No
  5. * Do you have demonstrated experience in a complex administrative support position with responsibility for operations related to the programmatic and financial management of clinical research programs?
    • Yes
    • No
  6. * Do you have demonstrated experience with federal online reporting policies and procedures?
    • Yes
    • No
  7. * Do you have demonstrated proficiency in computing (including word processing and database management)?
    • Yes
    • No
  8. * Do you have demonstrated proficiency in spreadsheet analysis and electronic mail systems?
    • Yes
    • No
  9. * Do you have demonstrated supervisory experience?
    • Yes
    • No
  10. * Do you have demonstrated strong interpersonal and verbal communication skills?
    • Yes
    • No
  11. * Do you have demonstrated proficiency in written communication skills?
    • Yes
    • No
  12. * Do you have demonstrated ability to work with diverse populations/groups?
    • Yes
    • No
  13. How did you hear about this employment opportunity?
    • Public Job Posting
    • Internal Job Posting
    • Agency Referral
    • Advertisement/Publication
    • Personal Referral
    • Website
    • Other