- 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.
- Minimum five (5) years of clinical trials research involving human subjects
- Minimum three (3) years of supervisory responsibility/ project management experience
- Bachelors Degree.
- N/A
- Supervisory experience required.
- Proficient in electronic health systems and data bases used in research environment and word processing and database software.
- Demonstrate organizational and communication skills.
- Demonstrate written, verbal, and interpersonal communication skills.
- Demonstrate proficiency in medical terminology.
- Demonstrate attention to detail and accuracy.
- Ability to manage multiple tasks.
- Demonstrated prioritization and organizational skills.
- Ability to problem solve complex issues.
- Ability to be flexible and dependable.
- Ability to work effectively on cross-functional teams.
- Present professional manner and appearance.
- Maintain ongoing professional development.
- In-depth knowledge of the principles, methods and procedures of basic medical and/or clinical research processes.
- In-depth knowledge and understanding of human research protection regulations, policies, procedures, and standards as applied to IRB and compliance operations.
- In-depth knowledge of clinical trials research and research regulations.
- In-depth knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures.
- Must be able to work in a Labor/Management Partnership environment.
- Extensive clinical trial experience in a specific therapeutic area.
- Clinical Trials Research Experience Preferred
-
Clinical Trial Manager
1 week ago
i-Pharm Consulting San Diego, United StatesJob Title: Clinical Trial Manager - Rare Disease · Location: San Diego, CA (Hybrid working model, remote candidates with exceptional qualifications may be considered) · Overview: · Lead the planning, execution and management of clinical trials for innovative rare disease treatmen ...
-
Clinical Trial Manager
3 weeks ago
Alterome Therapeutics San Diego, United StatesAbout Us: · Alterome Therapeutics, Inc. was formed in December 2021 and officially launched operations in January 2022. We are a precision oncology biotech developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. The company is led by a t ...
-
Clinical Trial Manager
2 weeks ago
Boundless Bio San Diego, United StatesBoundless Bio is a publicly traded (Nasdaq:BOLD), San Diego-based, clinical stage oncology company employing an exciting new area of cancer biology, extrachromosomal DNA ("ecDNA"), to revolutionize the way cancer is treated. Reporting to the Associate Director, Clinical Operation ...
-
Clinical Trial Manager
4 weeks ago
Boundless Bio San Diego, United StatesBoundless Bio is a publicly traded (Nasdaq:BOLD), San Diego-based, clinical stage oncology company employing an exciting new area of cancer biology, extrachromosomal DNA ("ecDNA"), to revolutionize the way cancer is treated. Reporting to the Associate Director, Clinical Operation ...
-
Clinical Trial Manager
1 week ago
Crinetics Pharmaceuticals, Inc. San Diego, United StatesClinical Trial Manager · Categories: Clinical Operations · Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists wit ...
-
Clinical Trial Manager
1 week ago
Equillium Inc San Diego, United StatesOverview of Position: · Managing and meeting the objectives of clinical studies and programs by ensuring successful conduct of assigned clinical programs consistent with applicable regulations, Good Clinical Practice (GCP) and current standard operating procedures (SOPs). Account ...
-
Clinical Trial Manager
1 week ago
iPharm San Diego, United StatesJob Title: Clinical Trial Manager - Rare DiseaseLocation: San Diego, CA (Hybrid working model, remote candidates with exceptional qualifications may be considered)Overview:Lead the planning, execution and management of clinical trials for innovative rare disease treatments at a s ...
-
Clinical Trial Manager
3 weeks ago
Alterome Therapeutics San Diego, United StatesAbout Us: · Alterome Therapeutics, Inc. was formed in December 2021 and officially launched operations in January 2022. We are a precision oncology biotech developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. The company is led by a t ...
-
Clinical Trial Manager
2 weeks ago
Alterome Therapeutics San Diego, United StatesJob Description · Job DescriptionSalary: $130,000 - $160,000/year based on skills and experience. · About Us: · Alterome Therapeutics, Inc. was formed in December 2021 and officially launched operations in January 2022. We are a precision oncology biotech developing alteration-sp ...
-
Clinical Trial Manager
3 days ago
Crinetics Pharmaceuticals San Diego, United StatesClinical Trial Manager · Categories: Clinical Operations · Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists wit ...
-
Senior Clinical Trial Manager
1 day ago
Tr1X San Diego, United StatesPosition Description · The Senior Clinical Trial Manager will play a key contributor role in the implementation and execution of clinical trial(s) from study start up to close-out. The incumbent will have responsibilities for the management and oversight of CRO's, study vendors a ...
-
Sr. Clinical Trials Manager
2 weeks ago
Artiva Biotherapeutics San Diego, United StatesAbout Artiva: · Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Our mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases ...
-
Clinical Trial Manager II
2 weeks ago
Fate Therapeutics, Inc. San Diego, United States Full timeFate Therapeutics is looking for a talented Clinical Operations professional to support our clinical studies. This position offers an excellent opportunity for a highly motivated individual to contribute to the successful coordination and execution of clinical studies with our iP ...
-
Clinical Trial Manager, Oncology
3 weeks ago
Planet Pharma San Diego, United StatesWe are working with a growing San Diego pharmaceutical client looking to hire a Clinical Trial Manager. The position is an initial 6 month (extendable) contract and they would like this person to work on-site 3 days a week. · RESPONSIBILITIES: · Contribute to the operational stra ...
-
Clinical Trial Manager II
2 weeks ago
BioSpace San Diego, United StatesJob Details · Fate Therapeutics is looking for a talented Clinical Operations professional to support our clinical studies. This position offers an excellent opportunity for a highly motivated individual to contribute to the successful coordination and execution of clinical studi ...
-
Senior Clinical Trial Manager
2 weeks ago
EPM Scientific San Diego, United StatesSenior Clinical Trial Manager · San Diego, CA (Hybrid) · $160,000 - $180,000 · Job Description · EPM is partnered with a trailblazing biotech nestled in sunny San Diego, dedicated to pioneering breakthroughs at the intersection of oncology and immunology. Leveraging cutting-edge ...
-
Clinical Trial Manager II
3 weeks ago
BioSpace San Diego, United StatesJob Details · Fate Therapeutics is looking for a talented Clinical Operations professional to support our clinical studies. This position offers an excellent opportunity for a highly motivated individual to contribute to the successful coordination and execution of clinical studi ...
-
Clinical Trial Manager II
3 weeks ago
Fate Therapeutics, Inc. San Diego, United StatesFate Therapeutics is looking for a talented Clinical Operations professional to support our clinical studies. This position offers an excellent opportunity for a highly motivated individual to contribute to the successful coordination and execution of clinical studies with our iP ...
-
Sr Clinical Trial Manager
4 weeks ago
Erasca, Inc. San Diego, United StatesErascais a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAP ...
-
Senior Clinical Trial Manager
1 week ago
EPM Scientific San Diego, United StatesSenior Clinical Trial Manager · Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants. · San Diego, CA (Hybrid) · $160,000 - $180,000 · Job Description · EPM is partnered with a trailblazing biotech nestled ...
Clinical Trials Manager - San Diego, United States - Kaiser Permanente
Description
: Job Summary: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.
Essential Responsibilities:
Experience
Scheduled Weekly Hours: 40
Shift: Day
Workdays: Mon, Tue, Wed, Thu, Fri
Working Hours Start: 08:00 AM
Working Hours End: 05:00 PM
Job Schedule: Full-time
Job Type: Standard
Worker Location: Flexible
Employee Status: Regular
Employee Group/Union Affiliation: NUE-SCAL-01|NUE|Non Union Employee
Job Level: Manager with Direct Reports
Department: Department of Research and Evaluation
Pay Range: $ $169290 / year The ranges posted above reflect the location in the job posting. The salary range may vary if you reside in a different location or state than the location posted.
Travel: Yes, 50 % of the Time
Flexible: Work location is on-site at a KP location, with the flexibility to work from home. Worker location must align with Kaiser Permanente's Authorized States policy. At Kaiser Permanente, equity, inclusion and diversity are inextricably linked to our mission, and we aim to make it a part of everything we do. We know that having a diverse and inclusive workforce makes Kaiser Permanente a better place to receive health care, a more supportive partner in our communities we serve, and a more fulfilling place to work. Working at Kaiser Permanente means that you agree to and abide by our commitment to equity and our expectation that we all work together to create an inclusive work environment focused on a sense of belonging and wellbeing.
Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status. Submit Interest