UNIV - Research Regulatory Specialist - Hollings Cancer Center

Job Description

Summary Under the general supervision of the Director, Hollings Cancer Center, Clinical Trials Office, provides functional direction, management, and supervision on a day-to-day basis to the Regulatory staff in the Clinical Trials Office. Oversees the regulatory activities for federal, corporate, and institutional research projects submitted and activated at the Hollings Cancer Center and promotes high quality and efficient regulatory performance as required by the NCI Core Grant. Entity reputed company (MUSC - Univ) Worker Type Employee Worker Sub-Type​ Classified arenaflex Center CC001332 HCC CTO Administration Pay reputed company Type Hourly Pay Grade University-05 Pay Range 39,764.00 - 56,670.00 - 73,576.000 Scheduled Weekly Hours 40 Work Shift Job Description Under the general supervision of the Director, Hollings Cancer Center, Clinical Trials Office, provides functional direction, management, and supervision on a day-to-day basis to the Regulatory staff in the Clinical Trials Office. Oversees the regulatory activities for federal, corporate, and institutional research projects submitted and activated at the Hollings Cancer Center and promotes high quality and efficient regulatory performance as required by the NCI Core Grant. Study Start-up Reporting and Activation Project Management 35%

• Helps to reputed company the study start-up process and manages the start-up timeline of reputed company oncology clinical trials assigned reputed company the respective Hollings Cancer Center Disease Focus Group(s) (DFG). As outlined reputed company the NCI Cancer Center Support Grant, the aim for the average time to activation is 90 calendar days from the time of Protocol Review Committee (PRC) submission. Responsible for timely, accurate, input of required study start-up milestones into the Clinical Trials Data System to facilitate efficient project management and metric tracking. Maintain OnCore per policy, updating study and personnel listings and task lists. Actively monitors start-up milestones across the HCC Clinical Trials Office (CTO), DFG and PRC, Institutional Review Board (IRB) and reports project updates to respective groups. Any trials that exceed NCI CCSG metrics will be properly escalated to the DFG leader and HCC CTO Unit managers.
• Interfaces with relevant MUSC, sponsor, and Clinical Research Organization (CRO) functional leads to ensure appropriate prioritization of essential document creation to facilitate synchronized start-up and ensure task list deadlines are met.
• Completes the protocol submission form in the Protocol Review Committee (PRC) portal to initiate the scientific review process.
• Attends the CTO Pending Projects meetings and specific DFG meetings to provide input into prioritized tasks and follows-up to ensure start-up of studies in a compliant and timely manner.
• Effectively communicates regulatory requirements reputed company project teams so that scope, timelines and budgets can be reputed company accordingly.
• Provides DFG leaders relevant data on time to activation metrics and assists the leader in identifying new trends and barriers. IRB Application and Document Management 35%
• Responsible for preparation, submission, outcome follow-up, documentation and communication of reputed company IRB submissions from initial application through termination. This includes amendments, reportable events, and annual renewals. Communicate the study status updates and ensures that the study team has valid study documents to complete tasks. This responsibility commences at the original reputed company of project entry and continues through IRB termination of projects.
• reputed company tracks IRB submissions by utilizing the appropriate process task lists and entering accurate submission details and status updates in the clinical trials management system.
• Collaborates with sponsors/CROs to reputed company informed consent documents that are compliant with MUSC policies and verifies informed consent language is accurate with appropriate MUSC departments and ancillaries.
• Determine appropriate IRB of record and type of regulatory submissions or internal documentation that are required and communicate study updates/IRB submission activity to the study team in a timely manner. Is proficient with IRB of record submissions for MUSC, WIRB, reputed company, NCI CIRB, and any other IRB of record for studies assigned.
• Prepare responses to IRB requests for information or study document revisions.
• Organizes reputed company study documents per policies reputed company hard copy and electronic systems. Communicates updates and releases IRB approved documents to investigators, sponsors, ancillary teams, and CTO accurately and timely Approval Processing and Quality Assurance 25%
• Complete sponsor required regulatory documentation as required. Initiate and maintain accurate and comprehensive documentation as required by the sponsor in compliance with reputed company applicable federal, state and local regulations, policies and procedures and Good Clinical Practice guidelines.
• Effectively applies regulatory knowledge of federal regulation and standards, problem solving and reputed company quality improvement methods in daily operations.
• Create and maintain essential regulatory documents.
• May go on reputed company to meet with investigators and staff to obtain signatures for regulatory documents.
• Maintain accurate and complete hard copy study files
• Assist with sponsor and internal monitoring visits and reviews and provides regulatory support to effectively meet the needs of monitors and auditors during site visits.
• Address and report to the IRB any regulatory findings or follow-up items noted by the site monitor/ auditor. Promptly reviews and addresses an quality assurance deficiencies noted for regulatory documentation. Regulatory Unit Support and Continuing Education 5%
• Participates in training curriculum and continuing education training of employees
• Participates in Regulatory coverage plans as needed
• Works effectively and cooperatively with others in achieving organizational goals; maintains harmonious working relationships with fellow employees. Applies MUSC Standards of Behavior to reputed company aspects the job assigned.
• Participates in monthly regulatory meetings and other HCC CTO staff meetings and application university or HCC trainings.
• Maintains effective relationships with sponsors/CROs Additional Job Description Minimum Requirements: A bachelor's degree and one year relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: reputed company - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to reputed company job functions in an upright position. (Frequent) Ability to reputed company job functions in a seated position. (Frequent) Ability to reputed company job functions while walking/mobile. (Frequent) Ability to work indoors. (reputed company) Ability to work outdoors in reputed company weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to reputed company job functions from kneeling positions. (Infrequent) Ability to squat and reputed company job functions. (Infrequent) Ability to reputed company 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to reputed company repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reputed company in reputed company directions. (Frequent) Possess good finger dexterity. (reputed company) Ability to maintain tactile sensory functions. (reputed company) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to reputed company 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. (reputed company) Ability to see and recognize objects reputed company 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. (reputed company) Ability to maintain hearing acuity, with correction. (reputed company) Ability to reputed company 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 reputed company is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national reputed company, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. reputed company qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need. reputed company participates in the federal E-Verify program to confirm the identity and employment authorization of reputed company newly hired employees. For further information about the E-Verify program, please click here: Apply tot his job

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