UNIV - Program Manager I - Pediatrics: General Peds

Job Description Summary

Under the supervision of the Director of the Division of Pediatrics the General Pediatrics Research Manager assumes responsibility and accountability for managing the implementation of all clinical trials conducted by faculty in the Division of General Pediatrics. The Research Manager will perform clinical data collection and implementation of clinical trials and train the research team in these tasks. As the Research Program Manager, the position obtains and manages data from electronic data systems, meets with the physician and nursing teams responsible for the respective metrics, and assists with coordination of all research activities

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type

Research Grant

Cost Center

CC001020 COM PEDS General Pediatrics CC

Pay Rate Type

Salary

Pay Grade

University-07

Pay Range

Scheduled Weekly Hours

40

Work Shift

Job Description

Under the supervision of the Director of the Division of Pediatrics the General Pediatrics Research Manager assumes responsibility and accountability for managing the implementation of all clinical trials conducted by faculty in the Division of General Pediatrics. The Research Manager will perform clinical data collection and implementation of clinical trials and train the research team in these tasks. As the Research Program Manager, the position obtains and manages data from electronic data systems, meets with the physician and nursing teams responsible for the respective metrics, and assists with coordination of all research activities. The position supervises and directs staff assigned to various studies including budget management and coordination of all aspects related to enrolling patients. The Research Manager coordinates and manages all research activities in the South Carolina Pediatric Practice Research Network (SCPPRN) which includes 16 pediatric practices currently participating in research with the Division of General Pediatrics. The Program Manager insures adherence to IRB plan, submits and maintains IRB protocol documents for all studies, investigator initiated/grant protocols and insures compliance in the Division of General Pediatrics and with the practice-based research network (SCPPRN). The Program Manager advises junior faculty on their IRB submissions and serves as a resource for all faculty in regulatory matters.

Level of Supervision: This position would report to the Division Director of General Pediatrics. The employee will be supervised by the Division Director and also have a direct supervision by the SCPPRN Network Director on certain projects related to SCPPRN.

Minimum Requirement of the position: A bachelor's degree and three years relevant program experience.

State payband: 7

Duties:

35%

SCPPRN Coordinator: Serves as the MUSC General Pediatrics liaison to the South Carolina Pediatric Practice Research Network (SCPPRN) consisting of 16 community practices. Manages and maintains documentation of SCPPRN participating community practices and provides education to the practice personnel on conducting research. Assists the practice-based research network director in recruiting practices for participation in the network and in network activities. Organizes quarterly conference calls of entire network and organizes other network meetings, including the SCPPRN Annual Meeting. Maintains communication with network participants including having a staff contact at each practice. Insures that the practice contact list is up to date. Manages the implementation of research projects in the network practices who are participating. Plans and carries out data collection activities and data entry for network projects. Performs Practice Facilitation duties as needed in network practices. Assists in the preparation of funding requests for practice-based research network projects including coordination of activities, budgeting, timelines, and retrieval of needed information. Assist the research network director and the PI of individual practices in carrying out research and education in the network. Assists practices in updating and maintaining their FWA numbers and assists new SCPPRN practices with obtaining their initial FWA number. Coordinates IAE agreements with each new practice and the MUSC IRB and assures the agreements are approved and on file. Manages demographic data from SCPPRN Practices which is collected periodically and provides demographic breakdowns for the SCPPRN Director upon request. Provides quality assurance and data query resolution. Generates data tables for the SCPPRN Director and participates in the development and editing of reports and data driven publications. Performs research via library for relevant publications for physicians.

35%

Clinical Research Coordinator: Plans and carries out programs for the recruitment, screening and enrollment and retention of patients in all clinical research studies. Research and identify potential clinical research opportunities and present to the director for participation. Assist in the preparation of funding requests for studies including coordination of activities, budgeting, timelines, and retrieval of needed information pertaining to the General Pediatrics research programs. Develops participant advertisement materials if needed in accordance with the protocol. Attends multiple investigator meetings including attendance at the division-wide research meetings required. Plans and directs the maintenance of documentation and record storage for all clinical research efforts. Ensures proper off site archival of study records. Maintains communication with study sponsors and schedules audits. Advises the PI’s of individual studies in the organization and assists with implementation of their research projects. Assists division faculty with and/or prepares paperwork to assure that network activities are compliant with the IRB, GME and student rules and regulations. Conducts random audits of enrollment in all studies to verify eligibility requirements exist and to ensure accuracy of data, timeliness of reports and maintenance of protocols with the IRB. Develops procedures and corrective action plans in response to audits. Manages site visits by study sponsors. Provides Staff education of protocols for new studies. Manages and coordinates work of research assistants hired for research studies including routine audit of their files. Performs patient teaching regarding research studies. Reconciles and manages payments received with study budgets to ensure payments to patients who are participating in clinical research per Department rules. Coordinates with Department accountants concerning payments from study sponsors.

25%

Research Manager for Division of General Pediatrics:

Serves as the central research coordinating entity for researchers in the Division of General Pediatrics and supervises research assistants in the division.

Research Coordinator: Manages daily operational activities for research in the Division of General Pediatrics. Along with division faculty, complete paperwork to assure that network activities are compliant with the IRB, GME and student rules and regulations.

Screens, hires and evaluates Program Assistants and/or Program Coordinators. Performs their yearly reviews in a timely matter and successfully uses OurDay. Performs Planning Stages with Employee yearly.

Assists trainees with completion of IRB submissions for any initiatives (research or QI) for which they have a Division of General Pediatrics mentor.

5%

Miscellaneous Duties:

Serves as a member of the S.C. DHEC Immunization Task Force representing the Division of General Pediatrics and provides input to the Statewide Committee. Prepares study feedback reports and relay study related information to the research teams during regular meetings. Occasional state-wide travel to facilitate research projects and attend TRANSFORM SC Meetings.

Additional Job Description

Minimum Requirements: A bachelor's degree and three years relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lift objects, up to 15 lbs., from floor level to height of 36 inches, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to match or discriminate between colors. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)

If you like working with energetic enthusiastic individuals, you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees