UNIV - CTO SIS Unit Protocol Writer - Hollings Cancer Center
Medical University of South Carolina
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- Charleston, South Carolina
- Administrative, Operations, Program, & Project Management
- Business Operations
- Full Time
Job Description Summary
Investigator-Initiated Trial Support. Under the guidance of the CCSG Program Manager, this individual will work closely to oversee the study and site management of Investigator Initiated Trials (IITs) being conducted at Hollings Cancer Center. HCC IITs may be single center or multicenter. The purpose of this role is to ensure that HCC IITs are prepared and implemented according to Good Clinical Practice guidelines and federal, state, and local requirements at all participating locations. This individual will conduct administrative duties associated with the sponsor responsibilities of HCC IITs, including but not limited to: developing documents to guide the conduct of investigator-initiated clinical research (protocols, source documents, and data collection forms). This individual will work closely with departments across campus who are involved with developing or conducting HCC IITs and other NCI designated cancer centers in the US.Entity
Medical University of South Carolina (MUSC - Univ)Worker Type
EmployeeWorker Sub-Type
ClassifiedCost Center
CC001332 HCC CTO AdministrationPay Rate Type
SalaryPay Grade
University-07
Pay Range
Scheduled Weekly Hours
40Work Shift
Job Description
Job Description:
HCC investigator Trial Concept Support- 30%
Provides support to the SISU Manager in managing the intake of new MUSC investigator oncology trial concepts. Administers meetings and assures timely progress of review and start-up activities. Conducts literary searches of publications related to trial concepts and may support the drafting of background and rationale. Searches CTO.gov trial listings and reviews other past trial documents to support the protocol writing of new HCC investigator-initiated trial (IIT) protocols. 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. Consults with principal and co-investigators, biostatisticians, translational lab scientists, and leaders of the Hollings Cancer Center Advisory for Rapid Translation to supporting the growth of the HCC IIT pipeline. 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. Assures accurate status reporting of trial concepts and activation milestones within Pending projects meeting forums and other reporting requests.
Investigator-Initiated Protocol Management - 20%
Responsible for the development and implementation of clinical trial protocols and related documents, source documents, and data collection / case report forms with the guidance of Principal Investigators and Sub-Investigators. Maintains data collection instruments (patient reported outcomes / questionnaires, and/or surveys). Coordinates and participates in initial and ongoing protocol team meetings with investigators and support staff as indicated. Revises study documents per investigator, HCC Protocol Review Committee (PRC) and MUSC institutional Review Board (IRB), and Food and Drug Administration (FDA) requirements. Assist investigators and clinical research staff in providing initial protocol training and ongoing training with protocol amendments, revisions to policies and procedures, answering questions from clinical, regulatory and financial support staff. Identifies and resolves issues with clinical trial operations as appropriate. Maintains and manages electronic study files for IITs. Develops and communicates clear timelines for data submissions to clinical research staff. Works with CCSG Program Manager to prioritize submissions based on established criteria per institutional and NCI guidelines.
Study and Site Management - 20%
Acts as the primary liaison with the study teams and ancillary services at each participating center for questions regarding protocol implementation and data entry to ensure the study is implemented as required per protocol, Good Clinical Practice Guidelines, and the Code of Federal Regulations. Ancillary services include, but are not limited to investigational pharmacy, the translational science lab, pathology, radiology, etc. Ensures the study teams are trained on protocol requirements to ensure patient safety. If deficiencies are noted, communicates with sites to identify process improvements and/or re-train on the protocol as needed. Submits protocol and accrual information into the NCI’s Clinical Trial Reporting System (CTRP).
Will be knowledgeable of clinicaltrials.gov reporting requirements and will coordinate with biostatistics to ensure results are submitted to clinicaltrias.gov within the required timeframes. Partners with the translational science lab to ensure the study lab manual is drafted prior to study activation and meets the needs of the study and participating centers. Ensures samples are received and acceptable; if not, coordinates appropriate trainings for process improvements. Collaborates with investigational pharmacy and drug provider to develop pharmacy manuals. Develops study specific operations manual to detail how to submit data, reportable events and general regulatory requirements for each participating center.
Data Management – 10%
Acts independently as the sponsor resource for data collection for participating sites. Establishes a data collection and oversight plan (to include CRF completion deadlines and the risk-based monitoring plan) prior to activation and implement the plan while the study is active. Responsible for developing study specific databases for assigned investigator initiated trials. Works with investigators and study statisticians to ensure that data collection materials are adequate and collect study endpoint data appropriately. Develops training materials (PowerPoints, video, in-person) and train study team members on how to enter data in the EDC. As the study protocol is amended, updates the electronic data capture system (EDC) as needed. Acts as the primary contact for questions regarding the study database. While the study is ongoing, monitors and source data verifies data entered into the electronic data capture system and identifies trends. Issues queries to the study site regarding any missing and incorrect data and reports any major issues to the local Principal Investigator and Sponsor-Investigator as needed. Tracks case report form submission to ensure data is up to date and entered in a timely manner and will issue a CRF due email to participating centers as needed. As needed, compiles data for reporting to the sponsor-investigator, funding sources and others, as appropriate.
Investigator Initiated Trial Eligibility Review and Enrollment– 10%
Responsible for independently conducting eligibility audits on all subjects enrolled to assigned investigator initiated trials (IITs) to ensure that all subjects enrolled to the trial are eligible the source documents support trial eligibility. Maintains an enrollment log for all trials to include subjects enrolled across all participating institutions and will submit to Sponsor-Investigator and/or funding source as required per the study. For randomized trials, retains the randomization model and works with biostatistics to ensure the model is maintained appropriately throughout the life of the trial. Reports subject enrollments for non- MUSC patients in the CTMS system. Reports enrollment milestones to outside funding sources.
Regulatory Management – 10%
In collaboration with the SISU Regulatory Coordinator, ensures PRC, IRB and FDA submissions are accurate. Coordinates with the SISU Regulatory Coordinator to develop the informed consent form, patient materials and other regulatory documents as needed. Assists in the compilation of FDA IND annual reports, including, but not limited to, providing relevant data (AEs, SAE, patient status and patient demographics). Provides coverage for the SISU Regulatory Coordinator as needed.
MUSC Minimum Training and Experience Requirements:
A bachelor's degree and three years relevant program experience.
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 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)
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.
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
This job is no longer accepting applications
See open jobs at Medical University of South Carolina.See open jobs similar to "UNIV - CTO SIS Unit Protocol Writer - Hollings Cancer Center" Charleston Region.