Job Description

Summary:
Under general supervision but following established policies and procedures performs scientific investigative research in areas related to patient care. Researches literature in the field may participates in the design of experimental protocols and develops new procedures to carry out established research objectives. May be responsible for IRB protocol submissions (amendments continuing reviews and adverse events). This individual may also screen patients for protocol eligibility obtain informed consent and register study participants to clinical trials. May assist in writing presentations and papers for publication based on the research performed

Responsibilities:

Prepares and maintains study record enters data via computer and may perform statistical analyses of resultant data.

May perform EKG�s and take vital signs during research-based monitoring tests. May also perform blood spinning and shipment of blood and tissue samples as required by protocol.

Performs data collection and management of patient clinical information as it pertains to participation in clinical trials via medical record review and/or patient interview. 

Ensures timely collection of protocol related samples including shipment to outside entities as required. 

Maintains regulatory binders and ensures study compliance with all state federal and IRB requirements.

Participate in clinical trial start-up process from receipt of protocol through IRB submissions site activation activities interim monitoring visits and close-out procedures. 

Responsible for data reporting and management collection of source documents use and development of case report forms adverse events reporting filing and archiving of study records and resolution of data queries.

Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders enter all required study data on an ongoing basis.

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

Establishes and maintains study record for each participant. Interviews patient and/or family to explain the nature of the study eliciting cooperation and gathering information to complete study questionnaire. Facilitates obtaining informed consent. May assist to schedule patient appointments and make calls to patients to complete documentation.

Reviews medical records to abstract information necessary to complete forms. Requests and follows up on missing data such as laboratory test results and the like.

Regularly monitors adherence to protocol; alerts physician when laboratory tests ordered have not been performed medication protocol not followed etc.

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. Gathers tabulates graphs develops explanatory charts and analyzes data using statistical methodology. Performs computer-assisted statistical analysis such as multiple antecedent variables linear regression frequencies cross-tabulation and the like. Writes non-complex programs using computer and software-compatible language to reformat information create new files etc.

Ensure all study related samples are collected properly prepared and shipped according to the protocol requirements and IATA/DOT regulations. May be responsible for tissue sample work

Responsible for organizing and preparing for both internal and external auditing and study monitoring visits. 

May provide functional guidance to subordinate research staff assigned to the project to provide clarification of protocol resolve issues ensure adherence to research protocol procedures and assist in developing their professional skills in reviewing and interpreting statistical trends and the like.

Regularly reviews relevant literature to research being conducted in order to better understand the project. Maintains and enhances professional expertise through educational opportunities and participation in related teams and conferences.

May perform research-based EKG�s 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.

In collaboration with the research investigator may participate in the design of experimental protocols to achieve the scientific objectives of the research project. May develop research methodologies within the parameters of experimental protocols and research objectives to allow quantitative and qualitative evaluation and interpretation of data obtained.

Other information:
BASIC KNOWLEDGE:Bachelor�s Degree in Applied or Life Sciences or related area including courses in research methodologies and computer systems. Knowledgeable in Good Clinical Practice. 

EXPERIENCE:

Two to three years progressively more responsible and related experience in the research field. Experience should demonstrate effective working knowledge of PI-initiated studies and/or industry-initiated studies statistics research methodology and an in-depth knowledge of the scientific field in which the research is being conducted. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred. Excellent organization and communications skills required. Strong interpersonal skills; ability to effectively interact with all levels of staff and externals contacts. Must be detail oriented and have the ability to follow-through. Ability to effectively manage time and prioritize workload. Must always practice discretion and adhere to hospital confidentiality guidelines. Must have computer skills including the use of Microsoft Office.

WORK ENVIRONMENT:

Completion in office clinic and laboratory environment with possible exposure to human serum chemical reagents and radioactive materials.

SUPERVISORY RESPONSIBILITY:

Provides functional guidance to subordinate research staff assigned to the project.

Brown University Health 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. Brown University Health is a VEVRAA Federal Contractor.

Location: Rhode Island Hospital USA:RI:Providence

Work Type: Full Time

Shift: Shift 1

Union: Non-Union

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