UNIV - Research Program Coordinator II - Journeyman - Department of Neurosurgery

Medical University of South Carolina•Charleston, SC

7d•$53,142 - $90,372•Onsite

About The Position

The Research Program Coordinator II–Journeyman Coordinates program design, implementation and daily administrative activities. Coordinates service delivery processes for programs administered by an agency. Conducts special projects at management's request; prepares and presents reports. Provides direction and guidance to staff concerning program issues. Attends legislative, public and advocacy group hearings; presents information for discussion and/or decision-making purposes; responds to requests for information. Reviews program objectives to determine compatibility with agency's mission; assesses programs and implements policy, procedure or rule changes. Participates in the management of the agency; attends agency planning sessions, recommends allocation of resources, provides feedback to employees and agency head and encourages employee growth and development. Will lead and/or oversee the implementation and day-to-day operations of multiple complex research studies or a large research grant. Responsible for conducting all research related activities within a portfolio of assigned clinical trials. Works directly with patients, study staff, Principal investigators (PI) and study sponsors to ensure institutional and Internal Review Board (IRB) compliance and that the integrity of the study is maintained. Coordination and management of industry sponsored and investigator-initiated trials involving subject screening, enrollment, data collection, scheduling visits, and conducting follow up visits. Responsible for maintaining regulatory documents, logs, and reporting adverse events and protocol deviations to appropriate agencies. Will serve as a research subject matter expert or resource across research domains and areas and will have the ability to train others on and apply research regulations to a variety of scenarios.

Requirements

A bachelor's degree and three years of relevant program experience.
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 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 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 determine distance/relationship between objects; depth perception. (Frequent)
Good peripheral vision capabilities. (Continuous)
Ability to maintain hearing acuity, with correction. (Continuous)
Ability to perform gross motor functions with frequent fine motor movements. (Frequent)

Nice To Haves

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 lift and carry 15 lbs., unassisted. (Infrequent)
Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent)
Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent)

Responsibilities

Review all research protocols, submissions, and all required document for IRB submission and approval.
Prepare budgets for each project for submission to appropriate funding sources and the MUSC Office of Research Programs, so that they meet all IRB and FDA requirements.
Coordinate/perform the reporting and communications with the IRB, government agencies and study sponsors regarding adverse effects, study implementations, study renewals, study terminations, study close-out and other activities necessary for exceptional performance of all studies from inception to close.
Responsible for the Quality assurance of the assigned projects.
Liaison between investigators, sub-sites, and sponsors.
Liaison between the patient and the PI regarding patient enrollment and for the scheduling of treatments in conjunction with protocol timelines.
Collaborates with all members of the research team in developing and implementing strategies for the effective management of the research studies.
Coordinates with nurses, techs, and other hospital ancillary services required to meet successful study milestones.
Implements recruitment and enrollment strategies for the division.
Creates department/unit-wide policies and guidance regarding conduct of study visits and the consent process.
Collaborates with other sub-sites in enrollment productivity and assist Program Manager in handling multicenter trials.
Responsible for communication with sub-sites about contractual agreement, start-up site documents, training, and producing clean data.
Manages device logs and is responsible for the management of Investigational Products (IP).
Coordinate proper data management according to protocol requirements and protocol compliance, i.e. collect and record all data pertaining to study patients on specific (funded or unfunded) studies and submit on time to research bases.
Maintain up-to-date knowledge of the status of current studies.
Provides oversight and/or training to entire department or unit with regards to maintaining subject level documentation.
Oversees adverse event collection or provides expert guidance on identifying adverse events
Review, evaluate and report to PI on a monthly basis, as to the status of each study.
Coordinate journals for references, assist in protocol development.
Assist in dissemination of data.
Meeting data entry and producing clean data as required by sponsors in a timely manner.
Continuously examine and evaluate the effects of the research regimen on study subjects and contribute to the advancement of services provided to same in promoting health education and communication.
A research team advocacy to take the department and division to the next level of research mission.
Participate in department research activities as required.
Attend meetings and conferences required by the protocols.
Works with Program Manager at conferences on the agenda, minutes, and other required documents for a successful meeting.
Participate in writing and presentation of research reports and grant protocols.
Actively pursue additional grant studies and sources of funding for continued salary support.
Support Program Manager in newsletter or any correspondence to sub-sites.
Review workload and operating procedure of each research study and determine priorities and workflow.
Creates and develops complex databases using research methodology knowledge as necessary.
Serves as a departmental/ unit-wide resource.
Willing to travel and accept additional tasks as assigned by the Program Manager.