What are the responsibilities and job description for the UNIV - Research Program Coordinator II - Journeyman - Department of Neurosurgery position at MUSC Health?
Job Description Summary
The Research Program Coordinator II–Journeyman will lead and/or oversee the implementation and day-to-day operations of multiple complex research studies or a large research grant. They will be responsible for conducting all research related activities within a portfolio of assigned clinical trials. They also work directly with patients, study staff, Principal investigators 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. They are responsible for maintaining regulatory documents, logs, and reporting adverse events and protocol deviations to appropriate agencies. This candidate 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.
Entity
Medical University of South Carolina (MUSC - Univ)
Worker Type
Employee
Worker Sub-Type
Research Grant
Cost Center
CC000986 COM NSGY General CC
Pay Rate Type
Salary
Pay Grade
University-GEN09
Pay Range
52,100.00 - 70,300.00 - 88,600.000
Scheduled Weekly Hours
40
Work Shift
Job Description
Job Duties:
30%: Review all research protocols, submissions, and all required document for 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. Adherence to protocol requirements is a must. Liaison between investigators, sub-sites, and sponsors.
25%: 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. 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 timely manner.
25%: Liaison between the patient and the PI regarding consent forms for patient enrollment and for scheduling of treatments in conjunction with protocol time lines. Also collaborate with all members of the research team in developing and implementing strategies for the effective management of the research studies. Coordinate with nurses, tech, and other hospital ancillary services requirement for the successful study milestones. Implement recruitment and enrollment strategy for the division. Collaborate with other sub-sites in enrollment productivity and assist Program Manager in handling multicenter trials. Responsible in communication with sub-sites about contractual agreement, start-up site documents, training, and producing clean data. Works with Program Manager in conferences development such as agenda, minutes, and other required documents for successful meeting.
10%: 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.
5%: 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.
5%: Review workload and operating procedure of each research study and determine priorities and workflow. Willing to travel and accept additional tasks as assigned by the Program Manager.
Additional Job Description
Minimum Requirements: A bachelor's degree and three years of 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 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) 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)
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
The Research Program Coordinator II–Journeyman will lead and/or oversee the implementation and day-to-day operations of multiple complex research studies or a large research grant. They will be responsible for conducting all research related activities within a portfolio of assigned clinical trials. They also work directly with patients, study staff, Principal investigators 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. They are responsible for maintaining regulatory documents, logs, and reporting adverse events and protocol deviations to appropriate agencies. This candidate 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.
Entity
Medical University of South Carolina (MUSC - Univ)
Worker Type
Employee
Worker Sub-Type
Research Grant
Cost Center
CC000986 COM NSGY General CC
Pay Rate Type
Salary
Pay Grade
University-GEN09
Pay Range
52,100.00 - 70,300.00 - 88,600.000
Scheduled Weekly Hours
40
Work Shift
Job Description
Job Duties:
30%: Review all research protocols, submissions, and all required document for 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. Adherence to protocol requirements is a must. Liaison between investigators, sub-sites, and sponsors.
25%: 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. 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 timely manner.
25%: Liaison between the patient and the PI regarding consent forms for patient enrollment and for scheduling of treatments in conjunction with protocol time lines. Also collaborate with all members of the research team in developing and implementing strategies for the effective management of the research studies. Coordinate with nurses, tech, and other hospital ancillary services requirement for the successful study milestones. Implement recruitment and enrollment strategy for the division. Collaborate with other sub-sites in enrollment productivity and assist Program Manager in handling multicenter trials. Responsible in communication with sub-sites about contractual agreement, start-up site documents, training, and producing clean data. Works with Program Manager in conferences development such as agenda, minutes, and other required documents for successful meeting.
10%: 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.
5%: 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.
5%: Review workload and operating procedure of each research study and determine priorities and workflow. Willing to travel and accept additional tasks as assigned by the Program Manager.
Additional Job Description
Minimum Requirements: A bachelor's degree and three years of 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 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) 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)
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