Medical University of South Carolina UNIV - SIS Unit Program Coordinator II- Hollings Cancer Center in Charleston, South Carolina
Job Summary: 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: scientific review, consent and patient material development; FDA IND/IDE and other submission to federal regulators; IRB applications and amendments; monitoring and quality assurance activities; data safety monitoring plan development; clinicaltrials.gov and CTRP reporting. 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.
25% - Works closely with SIS Unit Manager, CTO Finance, and Principal Investigator in assisting with administrative aspects for investigator initiated research start-up. May help with developing the trial draft budget and estimated cost. May help with drafting or checking the letter of Intent applications to potential funding sponsors and working with the funding sponsor in the protocol editing and development. Develops informed consent documents and patient materials (drug diaries, patient flyers, patient information cards) specific to each protocol and in alliance with GCP guidelines. Submits to funding source and/or Sponsor-Investigator for approval as required. Prepares IRB and IBC applications for submission. Drafts Investigational New Drug applications/Investigational Device Exemptions for Submission to the Food and Drug Administration, which includes documentation to confirm regulatory and environmental compliance as well pre-clinical and clinical data. Works with the Sponsor-Investigator and other study personnel to respond to FDA comments. Acts as sponsor’s authorized contact for communication with the FDA on behalf of the Sponsor-Investigator. Modifies appropriate regulatory documents (FDA Form 1572, FDF, DOA) and obtains the required signature (as previously stated, as well as CVs) documents necessary for trial activation. Obtains any other required documentation (medical licenses, CITI training) Responds to IRB comments in time frame given by the IRB and helps to facilitate any protocol and/or consent changes required by the IRB. Submits any protocol changes to the PRC to ensure compliance with the HCC DSMP. Schedules start up meetings and teleconferences as needed. Ensures study team has appropriate documents for trial start up. Updates the CTMS system (Velos), Rapid, SharePoint, N: drive and other systems and document management tools in a timely and organized manner. Uses customer service techniques in maintaining collegial relationship with study members and escalates any issues appropriately. Registers trials in the clinicaltrials.gov and NCI’s clinical trials reporting program (CTRP) per federal regulations. The CTRP system is used by the NCI to determine what studies are being conducted at MUSC as part of the Cancer Center Support Grant (CCSG). The CCSG is what makes HCC an NCI designated cancer center. Proper reporting in CTRP is a fundamental piece of the CCSG. Reporting studies in CTRP also ensures that participating centers also get credit for their participation in the study at the time of their respective CCSG renewals. Clinicaltrials.gov registration is required per the federal government and this role will ensure that the studies conducted at HCC will maintain compliance with those federal regulations. - (Essential)
35% - Submits amendments to the scientific review committee, the IRB and FDA, as applicable. Responds to IRB comments and escalates to appropriate study team members as required. Revises informed consent documents as needed. Submits protocol deviations, serious adverse events and other reportable events to the IRB and data safety monitoring committee. Maintains updated study documents in the regulatory binder and prepares binder for audits. Ensures that the study team has access to current study documents. Updates the CTMS system (Velos) and the N: drive and other systems and documents management tools in a timely and organized manner. Drafts annual reports and safety reports to the FDA by compiling and aggregating clinical trial data for reporting in an acceptable format within the timeframes required by the FDA. Acts as liaison between subsites and MUSC/Sponsor-Investigator. Maintain records in clinicaltrials.gov and the NCI’s Clinical Trials Reporting Program (CTRP). Updates accrual records in CTRP to ensure accuracy to ensure information in the CTRP records is up to date and reflects the CTO IIT portfolio. Participates in CTRP user calls and relays to managers any new process or CTRP user updates. Provides data entry and reporting to ensure HCC CTO adherence to CTRP quarterly reporting requirements. Reporting the accruals and submitting updates to the record not only ensures that MUSC’s record is appropriately updated, but also the records of the participating cancer centers across the US. Accrual updates in this system are an essential piece of any CCSG renewal. Updates study records in clinicaltrials.gov, including status updates, record verification and amendments within the timeframes required by federal law, which requires a working knowledge of the requirements and how to submit the updates. Communicate with statistician to obtain appropriate clinical trial data analysis for results reporting requirements. Works with investigators, statisticians and other SISU coordinators to ensure that results data is entered as required - (Essential)
25% - Oversees sub-site start up to include receipt of feasibility review, execution of CDA, release of regulatory documents, informed consent review, subcontract execution, scheduling of site initiate teleconference/visit. Acts as liaison for all start up activities, including those not included above. Ensures the collection of all FDA and GCP required study documents to verify site credentialing and compliance to research policies and regulations for participating sub-sites. Examples of required study documents include, but is not limited to medical licenses, CVs, delegation logs, financial disclosures, 1572a, human research protections training certificates, amendment approvals, protocol page signature pages, continuing renewal approvals and DSMC responses. Maintains subsite shadow regulatory binder. Acts as liaison between site and internal auditors at the time of audit. Ensures sites have the most recent study documents available. Reviews and approves changes to informed consent and subcontracts. Tracks and approves invoices received from subsites. Tracks documents and proactively reaches out to study teams as needed to obtain current information and renew expiring documents. Updates the Clinical Trials Management System (CTMS- e.g. Velos), RAPID, SharePoint, N drive and other systems and document management tools in a timely and organized manner per policy. Uses customer service techniques in maintaining relationship with study members and escalates any issues appropriately. - (Essential)
10% - Facilitates the review of protocol deviations and serious adverse events for assigned IITs, including those submitted by participating subsites. Relays DSMC outcome to sites and works with sites to obtain appropriate responses for approval. Acts as liaison with site for audit announcements, obtaining audit documents and ensure audit responses are submitted by the due date. Assists with drafting and review of progress reports for DSMC review, which includes data export and communicating with stats to ensure appropriate data analysis - (Essential)
5% - Including but not limited to coverage of eligibility reviews, committee meetings and other study specific events. - (Essential)
Minimum Experience and Training Requirements : A bachelor's degree and two years relevant program experience.
Physical Requirements: 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 20/20 vision, corrected. (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)