Clinical Trials Manager

The Clinical Research Manager is a demonstrated expert operational leader position, which is responsible for overseeing the daily research activities of multiple FDA-regulated clinical trials and clinical research projects at multiple KPSC sites. The Clinical Research Manager possesses expert operational clinical research skills and knowledge, and proactively assumes increased responsibilities in supporting the assigned KPSC Principal Investigators (PI) and Physician Director, KPSC Regional Clinical Trials or designee, and other research staff. The Clinical Research Manager is identified as a role model, educator, coach, mentor, resource, and supervisor. This is a non- licensed position. This position must adhere to the positions scope of practice as outlined in the Major Responsibilities below and is also responsible for assisting in protecting the health, safety, and welfare of research participants.

• Compliance:


• Support and comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct).


• Adhere to Guideline for Good Clinical Practice (GCP), federal, state, and local regulations, and KP policies and procedures.


• With Clinical Trials Division, PI and/or designee, ensure compliance with KPSC IRB and Clinical Trials Standard Operating Procedures (SOPs).


• Monitor compliance with GCP standards and required study procedures in preparation for periodic site visits from Sponsors or others.


• Lead periodic research site internal compliance monitoring activities and programs.


• Assist the PI in the preparation of internal and external audits, and participate in the conduct of the audit and any responses required.


• Study Implementation:


• Assumes the overall responsibility for site personnel for the maintenance, security and confidentiality of participants paper or electronic data at each KPSC clinical research site.


• Lead and coordinate study initiation including: feasibility assessment, organizing and participating in pre-qualification site visits, and overseeing the space requirements for study-related equipment/supplies, etc.


• Proactively lead, coordinate and participate in Sponsor monitoring visits and follow-up on outstanding data queries and clinical trial inquiries with site coordinators.


• Respond to routine operational questions related to study protocol, and refer clinical questions and issues requiring medical decision-making to the PI, Regional Clinical Trial Physician Director or other licensed personnel, as appropriate.


• Proactively coordinate the development of tools, such as source documents and tracking forms, to assist with data collection at each KPSC clinical research site.


• Ensure each clinical research site collects documents and reports the research data to the appropriate licensed staff member and the PI for assessment in a timely manner as per the IRB-approved protocol.


• Proactively set the standards at each research site to coordinate and manage required protocol data collection for submission in a timely and accurate manner as required by Sponsor (e.g., weekly screening log, routine electronic data submissions).


• Lead and contribute as a key research member during study team meetings.


• Oversee the periodic audits of each KPSC clinical research site to ensure the pertinent data collection information is abstracted and case report forms (paper or electronic) are completed, and a database program to track all study activity including study enrollment and consents is maintained.


• Monitor recruitment, screening, and enrollment of potential participants utilizing specific protocol eligibility for all the KPSC clinical research sites.


• Develop processes to assist and review all responses to and resolutions to Sponsor data queries and delinquencies from each research site in a timely manner.


• Create systems and oversight processes to ensure that the informed consent process is conducted in a quality and compliant manner.


• Create standards for site-based team members to assist the PI within the scope of practice with the coordination of drug accountability requirements.


• Review any reported potential protocol violations/deviations with the PI and ensure the appropriate entities are notified in a timely manner.


• Provide support and education for protocol activities for all research sites.


• Work with the PI and R&E on developing potential protocol budget, if requested.


• Track clinical research finances with PI according to final negotiated clinical trial agreement and KP enrollment, if requested.


• Assist the PI and research staff to effectively coordinate any IRB research submissions.


• Maintain systems and resources to effectively communicate with and obtain required IRB documentation.


• Develop site-specific SOPs as needed to create transparent processes.


• Coordinate the training for research sites in the preparation of protocol specimens, if applicable, according to protocol for shipping or storage with adherence to IATA/DOT guidelines and certification.


• In conjunction with the site staff perform study closure activities including preparation and collection of close-out documentation, and preparation of study files for distribution to long-term storage.


• Leadership and Communication:


• Proactively communicate compliance and operational needs with internal and external parties, PI, Sponsor, Contract Research Organization (CRO), Physician Clinical Trials Division Research Administrator and/or designee, and Research and Evaluation Department.


• Education and Training:


• Lead, develop and implement the training and education regarding protocols for licensed and non-licensed staff.


• Participate in training, education, and development activities to improve own knowledge and performance sustain and enhance professional development.


• Act as a mentor to other non-licensed research staff on a regular basis for research-related training and resource questions.


• Attend KP site-initiated meetings for protocol training including Sponsor-initiated meetings, as requested.


• Quality Improvement:


• Selectively screen case report forms (paper or electronic) for completeness and compliance with protocol and appropriate regulations.


• Lead quality improvement activities, as requested, and initiatives for research program. Systems and Infrastructure.


• Adhere to departmental policies and procedures to ensure confidentiality, privacy and security of clinical research interactions and participant information, and responsible use of operational research databases in compliance with KP policies.


• Adhere to departmental policies and procedures to support quality implementation and conduct of clinical trials, and assure maintenance of research documentation in compliance with the protocols and KP policies and procedures.


• Participate with Physician Director and Clinical Trials Division Research Administrator and/or designee to identify and prioritize the development of clinical trials systems and infrastructure to maintain research quality and compliance at clinical trial sites.