UNIV - Research Protocol Writer - Hollings Cancer Center

Job Description

35% HCC investigator Trial Concept Support

Provides support to the SISU Assistant Director and the scientific leaders of the Hollings Advisory for Rapid Translation (HART) in managing the intake of new MUSC investigator oncology trial concepts.

Works with SISU Director and HART leadership to prioritize submissions based on established criteria per institutional and NCI guidelines.

Administers monthly and ad hoc concept meetings for the active monitoring of timely progress of concept review and development from intake until abandonment or trial activation.

Consults with principal and co-investigators, biostatisticians, translational lab scientists, and leaders of HART to supporting the growth of the HCC IIT pipeline.

Conducts literary searches of publications related to trial concepts and may support the drafting of background and rationale.

Utilizes approved tools for trial development. Searches trial listings and reviews other past trial documents to support the protocol writing of new HCC investigator-initiated trial (IIT) protocols.

Supports the drafting and editing of the protocol, informed consent, and other study specific documents such as but not limited to patient questionnaires, drug diaries, and trial summaries.

Reviews Investigator Brochures (IB) and package inserts to help draft drug administration, the risk profile, safety assessment language, study calendar and drug administration tables of a protocol document.

Utilizes the appropriate model documents for protocol documents, informed consent, regulatory and patient data collection instruments to support the rapid activation of new IITs.

Organizes collaborative meetings and follows HCC policies regarding new trial intake and document management, including rules of study entry and task list reporting in the clinical trials management system.

Must have strong project management and team communication skills to ensure that the HCC IIT pipeline expands and grow per HCC strategic goals.

Responsible for recording study status updates in a detailed, accurate and timely manner within the appropriate CTO systems OnCore, eReg, etc.

Assures accurate status communication of trial concepts and activation milestones within Pending projects meeting forums and other reporting requests.

Escalates delays in a professional and timely manner and supports corrective action initiatives.

35% HCC Investigator-Initiated Trial (IIT) Activation

Serves as the regulatory specialist to complete the Food and Drug Administration (FDA) Investigational New Drug (IND) application and Institutional Review Board (IRB) applications.

Works very closely with the PI, HCC Biostatistics Shared Resource, CTO study team and other relevant stakeholders in the development and activation process of new HCC IITs.

Ensures that each protocol follows that standard CTO activation process with assurance that the IIT is vetted by the clinical program managers, ancillary providers, and finance for trial feasibility.

Creates and revises study documents and applications per investigator, study team, HCC Protocol Review Committee (PRC) and MUSC institutional Review Board (IRB), and Food and Drug Administration (FDA) requirements.

Collaborates with investigational pharmacy and drug provider to develop pharmacy manuals and protocol drug sections. Responsible for the development and implementation of study specific data safety monitoring plans, which will be used throughout the life of the study to ensure reportable events are submitted to the HCC Data Safety Monitoring Committee (DSMC), IRB and FDA as required.

Coordinates and participates in team meetings with investigators and support staff as indicated to focus on the development and activation of the IIT.

Must be a good communicator and must be knowledgeable in Good Clinical Practice Guidelines, and the Code of Federal Regulations.

Follows the CTO task lists for study activation and participates with timely updates within internal CTO meetings to report on the activation statuses.

Maintains and manages electronic study files for IITs.

20% Will receive amendment requests from the SISU program coordinators and PI and track these changes within the development of new protocol, informed consent, or other IRB approved materials.

This role is responsible for creating the marked and clean copy changes and submitting the changes to the IRB or record and FDA IND as applicable.

This role must create an accurate summary of changes document and maintain a system of proper version control an effective release date records.

This role is responsible for maintaining the Trial master file and properly communicating to the other SISU members, PI, biostats, lab, and other protocol stakeholders the amendment status, changes and implementation.

10% Administrative Support of the HCC Advisory for Rapid Translation (HART) and any concept development meeting that includes taking minutes, scheduling meetings and preparing and presenting agenda items.

Special Projects and Additional Duties. Provide project management of special activities.

MUSC Minimum Training and Experience Requirements :

A bachelor's degree and three years relevant program experience.

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.

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