Fda Researcher Jobs in Rhode Island (NOW HIRING)

SUMMARY:
Under supervision of the Dept. Clinical Research Supervisor and the PI of the Center for Behavioral and Preventive Medicine and for the Stress Trauma and Resilience (STAR) COBRE Program. The following established policies and procedures, performs clinical research in areas related to operation of research projects including recruitment, implementation, project processes and outcome evaluation of the project. Researches literature in the field, may participate in the design of experimental protocols. Collects and analyzes data using statistical methodology. May assist in writing presentations and papers for publication based on the research performed.
Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another.
In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include:
Instill Trust and Value Differences
Patient and Community Focus and Collaborate
RESPONSIBILITIES:
Manage most aspects of these clinical projects to include: - Serve as the main contact for research participants throughout all aspects of the research study.

Identify patients meeting criteria for inclusion in clinical research studies ensuring research protocol eligibility requirements are met.

- Review medical records to extract information necessary to complete research data forms.

- Conduct the informed consent process, ensuring compliance with the protocol.

- Establish and maintain study record for each participant.

- Coordinate follow-up appointments, meet with study subjects and complete reimbursements.

- Maintain and update research study questionnaires, scripts and other study forms.

- Collect and organize patient data into appropriate format to maintain study database.

- Coordinate collaborative work with other investigators and/or sites.

- Help to coordinate audits and on-site visits by the sponsor and other groups.

- May participate in IRB filing and maintenance including project submission, IRB revisions, renewals and adverse event tracking while maintaining IRB compliance. -May assist in tabulating and reviewing data for publication as well as writing papers for publications.

- May assist Principal Investigator(s) with development design and data management specifics of new studies.

-Maintain and enhance professional expertise through educational opportunities and review of pertinent literature. The main projects covered by this position are:

1). BEAR-MOON Clinical Trial- a randomized clinical trial comparing two different, FDA approved surgical treatment options for ACL tears. While a graft taken from the patellar tendon is an established method of ACL surgery, the BEAR procedure is a newer treatment option that received FDA approval in 2020, having met all the required safety and efficacy measures. Brown University Health is one of 6 sites nationally participating in this clinical trial.

2). A long-term longitudinal study that followed patients 15 years post ACL surgery. Although we are done with patient follow ups, there is still work to do regarding the data analysis, uploading data to iClinicalTrials.govand presenting the findings in manuscripts for publication. This position may also participate in several smaller clinical studies within the Department.
MINIMUM QUALIFICATIONS:
BASIC KNOWLEDGE:

Bachelor’s Degree in Applied or Life Sciences with experience in clinical research methodologies. Clinical Research certification or certification eligible CITI Training for Human Subjects Research or similar training recommended but not required Requires valid driver’s license for travel to other clinic sites Demonstrated knowledge and skills necessary to support PI with human subject based research to include professional correspondence and interaction with research subjects, knowledge of research ethics, regulatory management and good clinical practice principles as related to clinical projects Strong organizational skills, ability to manage and prioritize multiple research project tasks

EXPERIENCE:

Minimum of 1 year of experience conducting and managing human subject trials is required, 2 years’ experience is preferred. Strong interpersonal skills Experience with Microsoft Word, Excel is required. Experience with IRBNet and REDCap preferred.

WORK ENVIRONMENT:

Office-based position with travels off-site for project related tasks to include but not limited to travel to various clinical sites for recruitment and enrollment of study subjects and travel to Brown University for research tests such as MRI. INDEPENDENT ACTION: Performs independently within the department’s policies and practices. Refers specific complex problems to the supervisor when clarification of the departmental policies and procedures are required.

SUPERVISORY RESPONSIBILITY:

Provides functional guidance to other research staff as necessary.

Pay Range:

EEO Statement:

Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.

Location:

Work Type:

Work Shift:

Daily Hours: 

Driving Required: