Job Description Summary

This position will manage and coordinate a long-term research project from inception through completion for a collaborative project between the State of South Carolina, Medical University of South Carolina (MUSC), and OCI, Inc. an early-stage pharmaceutical company. The first phase of this project is currently funded by the State of South Carolina with the project name “A Randomized Phase 1 Double Blind Placebo Controlled, Single-Dose, Sentinel Lead-in, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized OCI-B2 Suspension in Healthy Adult Volunteers up to 80 years”. The project is projected in 3 phases (1A, 1B, and 2) that are sequentially funded at the completion of the previous phase. This position will be in place through all of the funded phases provided that the study continues as outlined in the MUSC contract and Statement of Work. The potential for continuation of the position is dependent on demonstration of safety and efficacy of the inhaled drug.

As the administrative leader of this project, the person holding this position must operate with a substantial amount of autonomy and be willing to use sound judgment while adapting to a regularly changing environment that at times can require assistance that is outside their routine responsibilities. Accuracy, quality assurance, customer service, and effective communication are important requirements as this position engages with a wide range of individuals both internally and externally. This position is housed within the Pulmonary & Critical Care Division and will report to the project’s PI, Charlie Strange, MD and the administrative unit of the MUSC Vice-President for Research, Lori McMahon, PhD.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC004528 VPR Sponsored Activity

Pay Rate Type

Salary

Pay Grade

University-07

Pay Range

$52,357 - $74,613 - $96,869

Scheduled Weekly Hours

40

Work Shift

Day (United States of America)

Job Description

Job Duties:

20% - Manages the initiation and execution of the project in all phases. Defines project objectives and scope by reviewing project proposals to determine time frame, available funding, procedures, and various phases of project life cycle for major, multi-agency, or enterprise projects.

20% - Develops necessary documentation to support project initiatives including Investigational New Drug (IND) Application, research protocols, manual of operations, consent forms and case report forms. These documents will be edited for stakeholder requests and changes from original specifications with project sponsor and project teams.

20% - Report progress on budget and milestones to the State of South Carolina Budget and Control Board. Tracks and reports on project milestones to MUSC Office of Innovation. Validates reports provided by OCI Biotech on study recruitment, advertising, IND adherence, and clinical trial protocol fidelity. Reviews progress and status of all phases of the research protocols within the project and identifies specific activities to be performed to ensure project deliverables, milestones, and required tasks are completed according to project deadlines.

20% - Financial management of project at all phases to ensure budget adherence and compliance with state regulations. Manage subaward activities to provide oversight of project development and submission, ensure accurate and timely reporting of reconciliations, and reporting of grant activities. Manages the procurement process required by the project. Reviews requests and recommends changes from original statement of work with project sponsor, project team, or stakeholders.

10% - Determines and evaluates risks that may affect the project and implements a risk mitigation strategy. Creates quality management plans; develops and maintains project documentation; oversees project design to ensure compliance with federal and state laws and regulations.

5% - Direct management of clinical research coordinators for phase 2 protocol conducted at the Medical University of South Carolina. Oversight of subject recruitment and enrollment to ensure patient safety, scientific integrity, and regulatory compliance with the MUSC Office of Research and Sponsored Programs, the MUSC Institutional Review Board for Human Research for Phase 2 studies, and other state, federal, and institutional regulations.

5% - Primary MUSC liaison with project vendors, subcontractors, sponsor, and research staff on project activities. Oversees the development and execution of a communication plan which may include communicating with organizational leaders, elected officials, and the general public about the project’s impact or status. Prepares status reports and provides updates to project stakeholders, sponsors, and the University.

MUSC Minimum Training and Experience Requirements:

A bachelor's degree and three years of relevant project management experience. Some positions may require certification as a Certified Associate in Project Management or Project Management Professional (PMP).

MUSC 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 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. (Continuous)
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)

Additional Job Description

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 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. (Continuous) 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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