Public Administration Analyst - Clinical Research

T itle : Public Administration Analyst - Clinical Research

Location : 700 Tiverton Los Angeles, CA 90024. We will request courtesy parking but will need a 2-week advance notice to request the parking permit.

Clinical research regulatory experience is preferred, but general administrative background will suffice.

Duration : 3 month

REMOTE. Clinical research regulatory experience is preferred, but general administrative background will suffice.

SUMMARY STATEMENT

• The Clinical Research Specialist (CRS) will work with the Network Clinical Research Team and UCLA study teams that support the JCCC Clinical Research Unit, the Translational Research in Oncology-US Network (TRIO-US), in the set-up and conduct of
• Network clinical trials. The CRS will assist with the preparation of Network submissions to IRBs and with the review and preparation of Network site study consent forms.

The CRS will ensure that all study safety data (i.e. MedWatch's, SAEs, protocol waivers / exceptions, deviations / violations) are processed, recorded and reported properly to the Sponsor and IRB and / or FDA, as appropriate.

The CRS will assist with reviewing amendments, supplements, annual reports, controlled documents for FDA submissions and interact with the FDA, as required.

The CRS will prepare for and assist with Sponsor and internal / external monitoring visits and reviews for Network Regulatory monitoring.

The CRS will respond to and resolve sponsor queries-both written nand verbal.

The CRS will assist in updating the Network database and Network Study Regulatory Binders. The CRS will assist with tracking, maintaining, and keeping required regulatory documents current by conducting annual regulatory reviews and updates.

The CRS will maintain site and phone lists, required regulatory documents, and disseminate necessary study information to Network sites.

The CRS will assist with audits / regulatory inspections, participate in study initiation meetings and staff / team meetings, as required.

The CRS may also assist with, special projects, which pertain to unique ongoing trials, or perform other duties, as assigned.

TYPE OF SUPERVISION RECEIVED

The incumbent is expected to independently prioritize assignments and complete ongoing tasks following established Clinical Research Unit and TRIO-US Network procedures and regulatory guidelines.

Incumbent will seek guidance from team lead, direct supervisor, or Senior Management when there are conflicting demands.

In addition, the reporting structure of this position may require the incumbent to report on matters to CRU administrative staff who may not be members of the home department for this position.

Time reporting, requests for vacation and other similar matters will be addressed with the direct supervisor or Senior Management.

A work performance evaluation will be undertaken on an annual basis.

HOW LONG HAVE THE DUTIES & TIME DUTIES AND TASKS

• 25% Clinical Research Pre-Study Preparation for TRIO-US Network Sites
• Assist with the coordination of study start-up for Network clinical trials; work with the UCLA Study Teams, IRB and Pharmaceutical sponsors and CROs for network site participation.

Prepare, compile and distribute required regulatory documents to study Sponsors for each assigned study conducted.

• Coordinate the preparation of study specific site lists for submission to Study Sponsors.
• In conjunction with the Team Lead and / or Regulatory Manager, establish and schedule study start-up dates and processes for the Network
• Assist in coordinating pre-site visits with the Network site study staff and the Network Investigators with Study Sponsors and Sponsor representatives.
• Assist Study Sponsors and Sponsor representatives with the distribution of required study supplies to the appropriate Network sites for study start-up and ongoing study needs.
• Assist in resolving any regulatory issues pertaining to study start-up with the Study Sponsor.
• Manage regulatory process for TRIO-US investigator-initiated trials and keep regulatory documents and approvals up to date to ensure that all study requirements are appropriately documented.

As needed, correspond with sit staff to ensure receipt of source documents for UCLA DSMB audits.

• Assist with clinical trials regarding Network study start-up requirements and regulatory processes.
• Attend study initiation meetings, and participate in team and general staff training events (i.e., teleconferences, webcasts, and / or meetings), as required.
• Prepare and make TRIO-US Network site submissions to the central IRB.
• Prepare and maintain Network Regulatory Binders.
• 8. Track and maintain required regulatory documents, which include lab certification / documents, CVs, IRB approval and compliance letters, medical licenses, and training certificates, to ensure that they are current and up-todate.
• Prepare and disseminate necessary regulatory documents to Network sites for study participation.

25% B. Clinical Research Responsibilities During Study

• Prepare, develop and review of Network regulatory submissions.
• Possess and utilize excellent written / oral communication skills
• Schedule monitoring visits and assist Network Research Staff and monitors to clarify and / or resolve any study and / or Network related issues.
• Compile and generate study and site specific reports, as assigned.
• Ensure that all data issues that can be resolved centrally are completed accurately with the Study Monitor.
• Respond to and resolve sponsor queries-written and verbal.
• Review monitoring letters and any outstanding issues with Regulatory Manager to be addressed and resolved as required by internal and external Network Research Staff.
• Assist the Central Network Research Staff in meeting and maintaining timelines for processing, opening, and ongoing management of studies.
• Review and ensure that any protocol deviations and / or violations identified in the course of data completion or monitoring activities are appropriately reported in the CTMS and IRB, as required.
• Ensure that all study safety data such as Med Watch IND Safety Reports, are recorded appropriately and reported per regulatory guidelines to the Sponsor, IRB, and FDA, as required, according to protocol and regulatory requirements, distributed to Network sites, and filed in the study files.
• Timely review, submission, and processing of SAEs, protocol waivers / exceptions, and protocol deviations / violations as required and per Sponsor and IRB procedures.
• Assist with audits & regulatory inspections, as needed.
• Maintain Network regulatory binders in a state of audit preparedness for Sponsor, FDA, and Quality Assurance audits and monitoring visits.
• Assist in quality control and quality assurance activities, including participation in internal QA audits and
• Sponsor / FDA audits as required.
• Assist with the development and implementation of ongoing processes to improve oversight and flow of communication with Network Sites.

25% C. Clinical Research Study Completion and Closeout

• In conjunction with Study Sponsor and Sponsor representatives, notify Network research staff and TRIO-US
• Finance team of all study closures.
• In conjunction with Network Research Staff, coordinate study closeout visits with Network Sites, as needed.
• Assist Team Lead and Regulatory Manager in ensuring that study closeout visits are arranged with the Central
• Network Research staff for final review and closeout of central study files.
• Assist with the collection of final study data. This will include regulatory documents and reference binders,
• Ensure review of final monitoring report with study monitor, Principal Investigator and Network study staff, as required.
• Assist the Central Network Research Staff in notifying all appropriate regulatory agencies of study closure, and assist with all study closure activities to ensure that the study has been completed appropriately.

25% D. General Research Responsibilities and Special Projects

• Assist the Central Network Research staff with any study, regulatory, and / or research related issues, as required.
• Participate in clinical research staff meetings and conferences, as required
• Attend investigator meetings and study meetings, as required.
• Attend Network teleconferences to discuss research studies, data collection and monitoring needs, and patient enrollment issues.

Attend JCCC, CRU, and TRIO-US staff meetings.

• Attend off-campus study and / or research meetings, as required.
• Prepare and review amendments, supplements, annual reports, controlled documents for FDA submissions and interact with the FDA.
• Evaluate changes to regulatory documents and formulate strategies to amend, as appropriate.
• Track, maintain, and ensure required regulatory documents, including but not limited to, lab certification / documents, CVs, IRB compliance letters, medical licenses, and training certificates are current and up-to-date.
• In collaboration with the Central Network Research Staff, develop tools, forms and processes as required to
• improve the oversight and flow of study information to Network Sites.
• Assist with tracking, maintaining updated regulatory documents for network sites by conducting annual regulatory reviews.
• Ensure all revised study consent forms for clinical trials are released and distributed to the Network sites, in a timely fashion.
• Work on additional special projects and perform other duties, as required and assigned by Senior Management

SKILLS, KNOWLEDGE AND ABILITIES TASK

REFERENCE IMPORTANCE

• Demonstrated working knowledge of current medical terminology specific to oncology, to accurately read and comprehend patient study information and record accurately and timely, information into study records and other appropriate research data forms.
• 2 years' experience in a Hematology-Oncology Clinical Research Network environment. All Required
• Demonstrated experience coordinating and overseeing multi-study and multi-site clinical research activities.
• Demonstrated knowledge of the processes, policies, and procedures of the JCCC Clinical Research Unit and affiliated Networks.
• Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards according to IRB, FDA, and GCP guidelines.
• Demonstrated knowledge of FDA and Sponsor regulatory requirements. Knowledgeable of
• Sponsor, QA, and FDA audit processes.
• Demonstrated knowledge of the principles, procedures, and ethical considerations in the conduct of clinical trials in an oncology setting.
• Demonstrated knowledge of the requirements for Network and Sponsor study and regulatory documentation.
• Ability to effectively oversee and manage a high volume of projects as well as adhere to stringent timelines.
• Ability to effectively train support staff.
• Clinical research experience, with in depth knowledge of clinical oncology as it pertains to clinical trials and studies.
• Demonstrated knowledge of "good clinical practices" for clinical research as defined by the FDA.
• Demonstrated organizational skills to efficiently and effectively provide project management, data management and monitoring support for multiple clinical trials and projects, providing accurate information in a timely manner.
• Demonstrated understanding of confidential information, how it is defined, and demonstrated skill in maintaining confidential status of such information.
• Demonstrated ability to prioritize workload to meet demands of the Clinical Research
• Team, Principal Investigators, Sponsor and FDA.
• Demonstrated knowledge of all components the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, patient care management, etc.
• Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and other to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.
• Ability to understand that work may be delegated by more than one person, depending on the individual needs of the Network sites clinical study and to carry out job responsibilities as assigned in a timely manner.

Notify direct supervisor of any conflicts in demand on time or priorities.

• Computer skills using PC platform computers with proficiency in Power Point, Excel, Word, Access FileMaker pro to enter data and generate correspondence accurately.
• Demonstrated English writing skills to generate original correspondence, including reports, using correct grammar, syntax and punctuation.
• Demonstrated English verbal skills to obtain and convey accurate information, explaining
• research protocol to patients and other staff.
• Ability to attend off-site staff meetings, conferences, and investigators meetings. All Required
• Required Qualifications : One year experience in clinical research in the subspecialty of
• Hematology-Oncology preferred; Knowledge and experience in a Network research setting.
• Research certification preferred. Demonstrated experience with multi-study and multi-site clinical research activities.

Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards as according to HIPAA, IRB, FDA, ICH, and

• GCP guidelines. Demonstrated knowledge of FDA and Sponsor regulatory requirements.
• Knowledgeable of FDA and QA audit processes. Demonstrated familiarity with the requirements for Network and Sponsor study and regulatory documentation.

Required knowledge of Microsoft Word, Excel, PowerPoint, Outlook, Internet Explorer, and FileMaker Pro.