Research Program Manager, PRMS

Job description


Job Description Summary:

The Research Program Manager, PRMS supports and coordinates the GW Protocol Review and Monitoring System Committees, namely Scientific Review Committees (SRC), Protocol Monitoring Committee (PMC) and Data Safety Monitoring Committee (DSMC). The manager will provide overall support and organization for all committee functions and responsibilities. Serves as a point of contact for all activities related to monitoring adherance to SRC/PMS policies and procedures as outlined in the Data Safety and Monitoring Plan (DSMP) adopted by GW Cancer Center as required by the Cancer Center Support Grant Guidelines (CCSG). The manager is responsible for: 1) the preparation of the agenda and review of materials prior to the committee meeting to assure that material required for review are available in accordance with the data safety and monitoring plan; and 2) fulfilling the role of liaison to Committee Chairmen, Program Leaders, Principal Investigators, Regulatory Specialists, and Study Coordinators.

Duties include:
-Responsible for thorough assessment of required data entry elements and timely accurate input of that data into the linical Trials Management System (CTMS) to facilitate efficient project management. This responsibility commences at the original point of project entry, continues through original IRB approval and Activation of the project, and is sustained through periodic monitoring of accuracy and clarity of data elements.

-Independently verifies submitted protocols meet requirements for placement on committee agenda by reviewing submitted form, protocol priority diagrams, and protocols prior to assignment. This function is carried out under the guidance of the Director of the CTO.

-Coordinates and attends Scientific Review, Protocol Monitoring and Data Safety Monitoring Committee meetings in accordance with Cancer Center Support Grant guidelines to ensure the success of the Cancer Center's protocol review and monitoring process. Responsible for compiling agendas, assigning committee reviewers, composing official minutes and constructing reports and correspondence in final form for GW review committees, all of which are components essential to the success of the Core Grant.

-Prepares DMC documents in collaboration with the study PI, including confidentiality agreements, conflict of interest statements and charters for each study requiring DMC review.

-Disseminates policy decisions and resolutions to GW study teams from the Scientific Review or Protocol Monitoring Committees

-Assists Principal Investigators in the development of protocol-specific DSMPs

-Coordinates travel and meeting arrangements for all DMC meetings

-Develops, improves and maintains systems for research information dissemination and work flow for prompt notification and efficient, accurate processing of all research-related activities. Maintains and updates templates and design; standardizes contemporary/innovative process methods and utilities. Also maintains accuracy of data in the CTMS tracking database and ensures the integrity of informatio non the Cancer Center website related to clinical trials.

-Develops, modifies and coordinates implementation of protocol tracking elements to provide added value to reports, resulting in greater efficiency and usefulness to users of the system and customres of Clinical Research Operation.

-Communicates with, guides, and educates GW investigators and all staff relative to questions and concerns pertaining to research protocols as well as facilitates preparation and submission/resubmission to the GW review committees.

-Educates investigators to ensure protocol specific requirements are obtained for scientific review of all projects.

-Assists in the training of new staff on various modules of the clinical trial management software (CTMS) used at the Cancer Center. Trains boars members and staff concerning functions of all committees (SRC, PMC and DMC). Responsible for maintenance of all instructional materials.

-Tracks Committee member attendance and service expirations and composes invitation or re-invitation letters, as appropriate, on behalf of the Associate Center Director for Clinical Research.

-Prepares operational review documents to the necessary ancillary services/programs. Facilitates communication between study staff and ancillary services/programs.

-Assists in policy and procedure development. Creates process-flows and Standard Operating Procedures, as required.

-Aids clinical trial study teams, cancer center staff and all other GW staff in identifying obstacles, and to develop and enact solutions. Investigate regulatory inconsistencies and reconcile them.

-Actively seeks continuing education. May partifipate in educational opportunities toward the goal of achieving certification in the field of clinical research. Enhances professional growth and development through educational programs and in-service meetings.

-Takes on special projects or tasks as required and needed by the Director of the CTO.

-Other duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

Minimum Qualifications:

Qualified candidates will hold a Bachelor's degree in an appropriate area of specialization plus 5 years of relevant professional experience, or, a Master's degree or higher in a relevant area of study plus 3 years of relevant professional experience. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience.

Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications: Preferred Qualifications:

-Bachelor's degree and a minimum of five years of clinical research experience; or,

-Master's degree and a minimum of three years of clinical research experience


Campus Location: Foggy Bottom, Washington, D.C. College/School/Department: School of Medicine and Health Sciences (SMHS) Family Research Administration Sub-Family Research Program Administration Stream Individual Contributor Level Level 3 Full-Time/Part-Time: Full-Time Hours Per Week: 40 Work Schedule: Monday through Friday Position Designation: Essential: Employees who perform functions that have been deemed essential to maintaining business or academic operations. Employees are generally expected to work from home during an event and may be asked to physically report to work. Telework: No Required Background Check: Criminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry Search Special Instructions to Applicants: Internal Applicants Only? No Posting Number: S007085 Job Open Date: 03/21/2018 Job Close Date: If temporary, grant funded or limited term appointment, position funded until: Background Screening Successful Completion of a Background Screening will be required as a condition of hire. EEO Statement:

The university is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.

Posting Specific Questions
Required fields are indicated with an asterisk (*).

    Applicant Documents
    Required Documents
    1. Resume
    2. Cover Letter
    Optional Documents
    1. Letter of Recommendation 1
    2. Letter of Recommendation 2
    3. Letter of Recommendation 3

    Documents needed to Apply
    Required Documents
    1. Resume
    2. Cover Letter
    Optional Documents
    1. Letter of Recommendation 1
    2. Letter of Recommendation 2
    3. Letter of Recommendation 3





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    Job No:
    Posted: 3/22/2018
    Application Due: 5/18/2018
    Work Type: