Regulatory Operations Manager

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's 20 leading cancer centers that develops and institutes standards of care for cancer treatment.

Requisition ID: 9980

Job Title: Regulatory Operations Manager

Position Summary and Key Responsibilities:

Under the direction of the Associate Director of the T Cell Therapeutics Research Laboratory (TCTRL) the Regulatory Operations Manager will be responsible for overseeing and leading the work of the regulatory support staff. The manager is also responsible for planning and maintaining work systems (Filemaker Regulatory Submission Tracker), procedures, and policies that enable and encourage the optimum performance of the staff and other resources within City of Hope. Regulatory Operations Manager will be responsible for the hiring, training, discipline of the regulatory support staff within the Immunotherapy Modality Team. The Regulatory Operations Manager will coach, mentor, and develop staff, including overseeing new employee on-boarding and will provide direction to the staff in accordance with the organization's policies and procedures. The individual will also ensure compliance and quality in the goal of meeting accuracy, timeliness, and comprehensive protocol submission to all regulatory committees.

Manages the team's effort to coordinate the generation, distribution, and creation of agendas and monitor meeting updates reflecting the protocol review activity from Principal Investigators and research staff. The Regulatory Operations Manager is responsible for reviewing and critiquing regulatory affairs associate's work product, ensures quality pre-review for research protocols to regulatory committees. Ensures that regulatory affairs specialists are correctly reviewing research protocols and monitoring their work and workload. Additionally, the Regulatory Operations Manager will advise staff of appropriate actions that should be taken in special circumstances.

Manages and actively supports the Immunotherapy Modality Team Investigational New Drug filings (including new INDs, amendments, exemptions, deviations, and annual and safety reports), and all related regulatory filings including but not limited to National Institute of Health Office of Science Policy filings with oversight and guidance provided by City of Hope Office of IND Development and Regulatory Affairs (OIDRA). Involved in planning, preparation and execution of all monitoring and auditing activities related to INDs and/or clinical protocols under their auspice.

Manages activities through the Integrated Research Information System (IRIS) and with OIDRA's work system relative to the Immunotherapy Modality Team. Other duties include: manages and maintains audit-ready files and refers difficult or problematic issues to the TCTRL Associate Director.

Manages the Regulatory Affairs Specialist(s) I-II assigned to them, interacts with staff as well as key personal developing the IND and clinical protocols such as investigators and their staff (clinical research nurse and coordinator, biostatistician, and scientific leads), industry sponsors, as well as Manufacturing, Quality Control, and Quality Assurance staff.

Essential Functions:

  • Prepares regulatory documents as required by institutional, state and federal laws and guidelines including and submitting to the local COH IRB, Cancer Protocol Review and Monitoring Committee (CPRMC), industrial clinical research sponsors, and Contract Research Organizations (CRO's) for review.
  • Perform all tasks related to the facilitation of the review, submission and approval process of a new protocol.
  • Knowledge of relevant federal and state laws, industry, regulatory, and institutional policies and guidelines.
  • Uses independent critical judgment in interpreting and applying knowledge in IRB protocol submission.
  • Collaborates with City of Hope personnel in audits, and in the deliberation with Federal, State, local agencies and organizations. Maintains master regulatory files
  • Manage the preparation and maintenance of reports necessary to carry out the functions of the department. Prepares periodic reports for management, as necessary or requested, to track strategic goal accomplishment.
  • Prepares regulatory documents as required by institutional, state and federal laws and guidelines including and submitting to the COH designated IRB, Cancer Protocol Review and Monitoring Committee (CPRMC), industrial clinical research sponsors, and Contract Research Organizations (CRO's) for review.
  • Recruits, trains, evaluates, disciplines staff.
  • Assists with developing performance goals and objectives.
  • Evaluates workload assessment of Regulatory Affairs Specialists.
  • Works with direct reports to resolve personnel issues.
  • Attends and participates in departmental staff meetings.
  • Supports staff training and development.
  • Leads in reviewing and critiquing the routine work product of the Regulatory Affairs Specialists; mentors and enables their professional development and growth in the field of regulatory.
  • Reviews the adequacy of the submissions (new protocols, amendments, conditions and corrections) to regulatory committees of the protocols and associated consent forms for accuracy and consistency.
  • Verifies and ensures the accuracy of detailed and highly complex correspondence, requiring a comprehensive level of knowledge of state and federal regulations and COH IRB/CPRMC and WIRB/CIRB policies and procedures, to PIs in order to assure that all concerns, rationales and technical questions of the regulatory committees are concisely communicated to PIs and that correspondence from the PI is accurately communicated back to the regulatory committees.
  • Interacts with the regulatory committees to help with advising the PI and/or PI staff of the appropriateness of the response and communicates any requirements not addressed in order for the PI to secure CPRMC/IRB/WIRB/CIRB/IBC approval of the study.
  • Maintains organized and accurate computer e-files, e.g., for the department, Ensures the Regulatory Affairs Specialists send to Clinical Trials on Line (CTOL) the approved file(s) of the study consent form(s) and an electronic copy of the protocol for posting. The consents are downloaded by authorized users for purposes of consenting potential research subjects. Since these consents are considered legal documents, accuracy and attention to detail are very important. Ensures that continuations are up to date in communication with iRIS and CTOL.
  • Ensures the Regulatory Affairs Specialists' creation of study consent forms/protocols if applicable for compliance with regulatory requirements and against established consent requirements. At the direction of the regulatory committees and using judgment, assists the staff in editing the consent form using established policies, procedures and conventions, and as necessary directly discusses consent issues with the PI or his/her staff to negotiate and clarify the necessary changes. Discuss any problems or issues with the TCTRL Associate Director as needed.
  • Develops and maintains daily operational procedures in performing all tasks related to the facilitation of the protocol/amendment submission and approval process.
  • Assists the Regulatory Affairs Specialists in working with the Clinical Trials Finance Office for clinical trials agreements, the Radiation Safety Committee (RSC), the COH Scientific review bodies (CPRMC and PRMC), the City of Hope and Western Institutional Review Board and the Institutional Biosafety Committee (IBC) (for gene transfer studies), making sure that these additional submissions are complete and department/committee approvals have been secured prior to release of the clinical trial for research subject accrual.
  • Takes leadership responsibility for prioritizing workload of the department and urgent requests submitted by PIs. Discusses prioritization issues with TCTRL Associate Director when necessary.
  • Monitors timeliness of the Regulatory Affairs Specialists', responses to the regulatory committees, following up with PIs.
  • Assists the TCTRL Associate Director with completion of other assignments as necessary.
  • With the assistance of the regulatory committees, assist the staff with applying knowledge of federal and state regulations, policies and guidelines to review and analyze protocol submissions.
  • Takes leadership role in drafting and/or editing new and existing Immunotherapy office procedures and standard work. Submits drafts for the TCTRL Associate Director and other Immunotherapy staff to critique and edit. Takes responsibility for ensuring that the staff understands and follows the department policy and procedures,
  • Participates in lean six sigma activities on a regular basis.
  • Manages employee work schedules including assignments, training, vacations and paid time off, and cover for absenteeism. Maintain transparent communication, one-on-one meetings and regular interpersonal communication.
  • Manage the preparation and maintenance of reports necessary to carry out the functions of the department. Prepares periodic reports for management, as necessary or requested, to track strategic goal accomplishment.

Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, includingadherence to theworkplaceCode of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.

Performs other related duties as assigned or requested.

Minimum Education and Skills Required for Consideration:

  • Requires a Bachelor's degree in a scientific discipline or equivalent.
  • A minimum of 5 years of related experience related to the management and conduct of oncology clinical trials in an academic setting.
  • Masters or RAPS certification in Regulatory Affairs or PhD in a scientific discipline is preferred.
  • RAPS, SOCRA or ACRP Certification and 7+ years of related experience in Regulatory Affairs, Clinical Trials Management or relevant scientific field is prefered.
  • Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.
  • Knowledge of Microsoft Office (Word, Excel, Powerpoint); familiarity with tracking system and regulatory management system.
  • Training or courses in Human Subjects Protections, Basic Biology (molecular and celluar), Chemistry (Inorganic, Oranic and Biochemistry), GMP facility operations, biosafety, chemical safety, cGMP principals would be helpful.

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.

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