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Clinical Research Administrator
Job DutiesThe mission of the Clinical Research Administrators team within DGSOM's Clinical Trials Administration Office (CTAO) is to assist faculty and staff navigate the pre-award process for clinical trials in a streamlined and expedited fashion and provide project continuity during the pre-study approval process. The goal of this position is to identify upcoming studies promptly and facilitate the processing of necessary regulatory submissions, budget development, coverage analysis, contracts, etc. in a proactive manner. This includes serving as a resource for investigators in communicating and trouble-shooting issues with the Office of Research Administration, Office for the Protection of Research Subjects, and other campus offices and departments involved in the clinical research pre-study process. The position will be a liaison and coordinate efficient workflow and turnaround of pre-study tasks with counterpart Contracts Officers and other pre-award staff. Establishing an effective and cooperative relationship with contracting, IRB, OCGA, CIRC, EFM, OIPA, and other administrative units is a key responsibility. This incumbent will establish a customer service relationship with a group of assigned faculty and staff. This position requires expertise in protocol feasibility and clinical trial budget development/negotiation, as well as a thorough understanding of all aspects of the required UCLA pre-award process as related to clinical trials/research.
A. As PI advocate, help facilitate the pre-award process for investigators (and their research staffs) pursuing industry sponsored clinical trials.
A.1. As a service of the Dean's office to investigators, the Clinical Research Administrator is responsible for managing client relations and serving as the primary point of contact for a group of assigned PIs and research staff for a full range of clinical trials pre-study facilitation.
A.2. Review and assess clinical research protocols to (1) analyze research protocols for clarity and feasibility and (2) identify study specific requirements and potential issues. Advise PIs/research staff on protocol requirements and issues, as needed.
A.3. Conduct preliminary budget reviews and formal Coverage Analysis, including but not limited to: collection and review of applicable budget and regulatory documents, coordination and receipt of final approved budget documents, and provide guidance/support to formal budget review committees.
A.4. Correspond with PIs and applicable study team members to address inconsistencies/discrepancies between the budget, informed consent form, and current protocol (e.g. "Coverage Analysis Progress Note"). Responsible for the review and certification of the following documents: Qualifying Clinical Trial (QCT) Form, QCT Supplement, Coverage Analysis Matrix.
A.5. Advise and assist clients in producing comprehensive and compliant study budgets that address all study related costs and clearly distinguish between "routine costs" and research procedures required by any given protocol. Provide complete budget development and sponsor negotiation guidance/assistance, upon request.
A.6. Coordinate with applicable Contracts Officers to help expedite the contracts process; identify upcoming studies promptly and alert CTAO team members; assist faculty and research staff in understanding required forms, documents, approval signatures and similar contracting information needs.
A.7. Coordinate with the Asst. Director, Director, CTAO staff, and collaborating Department budget contacts/committees to ensure preliminary review and identification of budget and contracting issues are resolved promptly.
A.6. Take lead responsibility for ensuring the PI/research staff is advised promptly and on the onset of any and all initial budget and contract issues. This may include an in person meeting with the PI and key staff along with the Contracts Officer and/or other CTAO staff. If no issues are identified during the preliminary review process, advise the client accordingly.
A.8. Coordinate with Contract Officers to perform a quality control review of all trials in process to assure consistency among informed consent, budget and contract documents.
A.9. Maintain current knowledge of pre-award activities for assigned portfolio of clinical trials in process, and appropriate management of sensitive timelines.
A.10. Hold routine meetings with assigned client base to (1) stay abreast of clinical trial interests of the faculty and specific upcoming trials, (2) report on status of clinical trials in process, (3) provide information on new policies, procedures, etc., (4) address specific training needs, and (5) obtain feedback on DGSOM CTAO customer satisfaction.
A.11. Monitor turnaround times for various pre-award processes (receipt of all required documents from dept., contracting, CIRC, IRB, etc.) and report to key stakeholders (CTAO Asst. Director, CTAO Director, clients, Div. Chiefs, Dept. Chairs); and coordinate efficient workflow and turnaround of pre-study tasks with Industry Contract Officers and CTAO staff, the Office for the Protection of Research Subjects, and the Office of Research Administration (including Extramural Fund Management).
A.12. Perform Quality Assurance reviews of institutional forms, budget documents, and informed consent forms produced by research staff. Working with the Contract Officers, perform comparative review of informed consent, budget, and contract language for consistency.
A.13. Participate in department budget committee review processes.
A.14. Help advise clinical research staff on proper study initiation processes.
B. Continuous process improvement and updating of policies, procedures, and website.
B.1. Continuously identify process improvement needs and contribute to the development and implementation of improvements. May participate on various working groups to address broader research process related projects.
B.2. Ensure DGSOM CTAO databases and website information regarding pre-award processes and other educational information are up-to-date. Assume responsibility for specific content areas for CTAO website.
B.3. Responsible for correspondence and management of CTAO general e-mailbox, including but not limited to: prompt response and/or confirmation of receipt, as applicable, within 1-business day of receipt; logging of new review requests in the applicable Coverage Analysis database; and forward/triage e-mails appropriately.
C. Develop and conduct training needs assessment and training programs.
C.1. Assess training needs and provide ad hoc training to clients as an integral part of the advocacy & facilitation duties under Section A. above.
C.2. Contribute to development and implementation of training materials and workshops under the leadership of the DGSOM CTAO Director and Assistant Director.
C3. Assist in the planning and execution of DGSOM CTAO educational activities such as the "Coordinator Forum."
C4. Actively participate in campus research forums and training sessions, including presenting when applicable and assigned by CTAO Director or Asst. Director.
D. Provide mentorship, guidance, and supervision to CTAO Clinical Research Analysts.
D.1. Providing training support and mentorship to Clinical Research Analysts focused on applicable rules, regulations, policies and processes that pertain to Coverage Analysis Policies/Processes/Review/Certification and Clinical Research Billing Compliance.
D.2. Contribute to the development and implementation of CRA training materials and the execution of training sessions under the leadership of the DGSOM CTAO Director and Assistant Director.
Job Qualifications1. Education: Bachelor's Degree, preferably in biological sciences.
2. Education: Nursing degree preferred.
3. CCRP, ACRP or similar research related certification preferred.
4. Min. Years of Experience: At least 3 years recent experience as a clinical research coordinator, clinical research unit manager, clinical trials office professional, nurse coordinator, or other professional position involving hands-on IRB submission and study budgeting duties.
5. Demonstrated expertise in protocol assessment, IRB submission, and clinical trials budgeting.
6. Strong working knowledge of the full range of pre-award activities related to clinical trials research (e.g., IRB, ISPRC, CIRC, CTRC, other regulatory approvals, etc.)
7. Knowledge of medical terminology.
8. Demonstrated mature clinical and independent administrative judgment and decision-making skills.
9. Experience working with faculty, administrators, and staff in an academic medical center, health care or university environment.
10. Knowledge of research regulatory requirements (including FDA and other federal and state regulations), GCP/ICH guidelines, and special requirements for drug and medical device trials.
11. Knowledge of current ICD and CPT coding and medical billing.
12. Familiarity with UCLA or similar organization pharmacy, path/lab, radiology and other ancillary services and research pricing.
13. Familiarity with industry contracting or the ability to learn and grasp basic clinical trials contracting concepts.
14. Demonstrated excellence in negotiating skills, including the ability to resolve conflict among various groups and individuals with diverse backgrounds and goals concerning sensitive and important issues. Proven ability to participate effectively in the planning and development of multidisciplinary, cross-departmental research programs and committees.
15. Ability to communicate effectively regarding the health sciences campus research process and related details to a wide audience (scientists, physicians, nurses, staff, sponsors, and the general public.)
16. Ability to design and manage efficient work processes, set and meet expected turnaround time goals on an ongoing basis and monitor, analyze, and improve processes on an ongoing basis.
17. Ability to be flexible and adapt within an ever-changing, dynamic, service-oriented environment.
18. Ability to operate effectively in a team environment.
19. Ability to set priorities of assignments to complete work in a timely manner when there are changes in workload, pressures of deadlines, competing requirements and changes in assignments.
20. Ability to establish and maintain cooperative and mutually supportive working relationships with faculty, administrators, staff, other campus units, UC system units, and sponsoring agencies and companies.
21. Skill in analyzing information, problems, situations, policies or procedures to define the problem, need or objective, identify relevant issues or concerns, formulate alternatives for resolution or new program development, and recommend alternative choices and implications for implementation.
22. Excellent written and verbal communications skills.
23. Familiarity with UCLA Medical Center (preferred) or similar organization computing systems and demonstrated ability to learn and utilize other databases and administrative software, including a future clinical trials information system.
24. Strong computer skills and the ability to learn new software quickly and thoroughly
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