Clinical Research Prgm Coord

 

Responsibilities:
RESPONSIBILITIES Reviews medical records to extract information necessary to complete forms. Requests and follows up on missing data such as laboratory test results adverse event forms and the like. Establishes and maintains study record for each participant.

IRB filing and maintenance including protocol development IRB revisions renewals and adverse event tracking while maintaining IRB compliance.

Coordinates all required submissions related to protocol physicians procedures adverse events to the protocol office – regulatory affairs and/or FDA.

Coordinates collaborative work with other investigators and/or sites.  Also coordinates audits and on-site visits by the pharmaceutical companies and any other appropriate groups.

Conducting the informed consent process and ensuring compliance with the protocol.

Coordinate follow-up appointments meet with volunteers and complete reimbursements including:
- Scheduling of X-ray CT MRI and related clinical appointments that meet volunteers’ schedule needs.
- Maintain and update research study questionnaires scripts and other parts of conducting human research studies.
- Collects and organizes patient data into appropriate format to facilitate data entry. Creates modifies as appropriate and maintains study database to meet needs for project.

May perform research-based physical performance tests vital signs blood spinning and shipping of blood and tissue products in accordance with protocol specifications. May assist in writing presentations and papers for publications based on research performed. Assists Principal Investigator(s) with development design and data management specifics of new studies and forms; may assist with tabulating and reviewing data results for publication and reporting.  Also assists in developing protocols intervention plans and subject recruitment.

May require outside travel to evaluate sites or for other grant-related reasons.

Maintains and enhances professional expertise through educational opportunities and review of pertinent literature.

 

Other information:

BASIC KNOWLEDGE:

Bachelor’s Degree in Applied or Life Sciences or related area including courses in research methodologies and computer software. Clinical Research certification or certification eligible CITI Training for Human Subjects Research or similar training. An interest in sports orthopaedics and/or musculoskeletal rehabilitation in highly preferred.

May require valid driver’s license where grant requires travel outside of hospital.

 

Demonstrated knowledge and skills necessary to support PI with human subject based research. This includes interaction through phone email and written correspondence with paients and volunteers to recruit and secure follow-up research visits. Will serve as the main contact for research volunteers with all aspects of research visits. Understand and follow human subjects inclusion and exclusion requirements.


EXPERIENCE:

A minimum of 3 years of experience conducting and managing human subject trials is required. Experience should demonstrate leadership skills and ability to effectively prepare and monitor budgets. Strong interpersonal skills Experience with Microsoft Word Excel Powerpoint and Redcap is required. Experience with IRBNet and EPIC preferred.

WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS:

While most duties are performed in an office environment the incumbent will also be exposed to the laboratory and patient care environments.  Any risk of exposure to contagious or noxious elements is minimized by adherence to safety procedures and protocols.   

 

 

Lifespan is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status.   Lifespan is a VEVRAA Federal Contractor.

 

Location: Rhode Island Hospital USA:RI:Providence

 

Work Type: Full Time

 

Shift: 1

 

Union: Non-Union