Job Description Summary
Clinical Research Coordinator to oversee/manage a portfolio of research studies within the Department of Neurology. Individual will be responsible for conducting and overseeing all research related activities within a portfolio of assigned clinical trials to include the coordination of study visits, management of study documents and promotion of study integrity/protocol compliance.
Entity
Medical University of South Carolina (MUSC - Univ)
Worker Type
Employee
Worker Sub-Type
Research Grant
Cost Center
CC000985 COM Neurology CC
Pay Rate Type
Hourly
Pay Grade
University-05
Pay Range
38,985.00 - 55,559.50 - 72,134.000
Scheduled Weekly Hours
40
Work Shift
Job Description
Band 5
Minimum:$35,360.00
Mid Point:$50,394.00
Maximum:$65,429.00
Job Duties
25%: Serves as lead coordinator on assigned projects to include following departmental policies and procedures and Good Clinical Practice guidelines, tracking recruitment, screening and enrollment of research participants, coordinating research visits with other members of the research team as needed to facilitate seamless study visits, managing data collection and data entry, reviewing documentation for accuracy and data validity as needed, and serving as a resource for and interacting with ancillary services (laboratory, radiology, investigational pharmacy) to prevent and or resolve any issues.
25%: Coordinates all phases of clinical trials regulatory management for assigned studies: (i.e. study start-up/initial submission, interim maintenance, annual renewals, amendment processing and closeout activities.) Under the direction of the PI, prepares all levels of regulatory documents for study implementation, ongoing maintenance, and amendments to include sponsor required documents, as well as local IRB documentation. Prepares and finalizes required Sponsor and Departmental regulatory/compliance reports.
20%: Coordinates roles and activities of research studies in collaboration with the TRU director/PI and finance team to ensure effective and efficient workflow that meets study/organizational goals. Records all financial activities of study for billing sponsors and paying subcontractors and vendors. Acquires, inventories, and stores protocol-specific research supplies. Retrieves and transports study drugs. Performs drug accountability and reconciliation tasks. Establishes research record in EMR system.
20%: Serves as a lead on special projects such as performing clinical assessments and rating scales for human subjects as required by study protocol. Perform safety assessments to include vital signs, electrocardiograms, blood draws, and lab processing. Works collaboratively with the TRU Director and other core members of the department to identify gaps in research tools and resources and develop new processes and tools to meet the needs of the research community. Disseminates these tools and resources to MUSC’s research community as appropriate.
10%: Participates in new employee orientation and training on the Code of Federal Regulations, and “Good Clinical Practices” (GCPs) to staff; provides oversight, guidance and mentorship, Research Interns, and other research personnel within the Department of Neurology and across departments on the day-to-day operations of conducting clinical research. Provides expert training to the MUSC research community on MUSC’s research processes and resources.
Additional Training and Experience Requirements
A bachelor’s degree and three years relevant program experience. Must be able to function independently with minimal supervision and act with discretion and confidentiality.
Must be self-directed individual with excellent communication and interpersonal skills. Must be a detail-oriented individual with excellent organizational skills. Must be able to manage multiple tasks successfully and work collaboratively with other professionals. Requires proficiency in use of Microsoft Office (Excel, Word, Powerpoint & Access).
Provides lead project management for assigned research projects to include Overseeing the day-to-day operations of assigned multi-disciplinary research protocols within the Department of Neurology. This senior coordinator role will also include following departmental policies and procedures and Good Clinical Practice guidelines, tracking recruitment, screening and enrollment of research participants, coordinating research visits with other members of the research team as needed to facilitate seamless study visits, managing data collection and data entry, IRB submissions and management, reviewing documentation for accuracy and data validity as needed, and serving as a resource for and interacting with ancillary services (laboratory, radiology, investigational pharmacy) to prevent and or resolve any issues.
Additional Job Description
Minimum Requirements: A bachelor’s degree and one year 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.
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