Clinical Trials Nurse Manager

Kaiser Permanente   •  

Pasadena, CA

Industry: Healthcare


5 - 7 years

Posted 240 days ago

This job is no longer available.

Description: The Clinical Trial Nurse Manager (CTNM) is an expert level position which, under the guidance and supervision of clinical trials administrative management and the Principal Investigator(s) (PI) and, provides clinical leadership to research team members, including clinical research nurses and research associates. The CTNM shows proficiency in and is responsible for ensuring that the integrity and quality of the clinical research trial(s) are maintained and conducted in accordance with federal, state and local regulations, Institutional Review Board (IRB approvals, and Kaiser Permanente (KP) policies and procedures. This position coordinates research activities for multiple clinical trials, including FDA-regulated trials, at multiple KP sites as outlined in the Major Responsibilities below. The CTNM is considered to be a critical thinker, self-directed, and an expert in a therapeutic clinical area as well as in clinical trials. This position independently and proactively assumes a significant decision-making and problem-solving role in complex research studies. This position is a nurse who can manage a single site or multiple research sites and directly hires and supervises other research personnel, as requested. This position is also responsible for protecting the health, safety, and welfare of research participants.

Essential Responsibilities:

  • Compliance
  • Support and comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct).
  • With PI and/or designee, ensure compliance with KPSC IRB approved protocols.
  • Adhere to Guideline for Good Clinical Practice (GCP), federal, state and local regulations, and KP policies and procedures.
  • Proactively lead in the preparation for, and actively participate in, internal and external periodic site monitoring/audit/inspection visits from Sponsor or other regulatory authorities.
  • Study Implementation:
  • Utilize expert nursing and clinical trial knowledge of disease processes to develop/support staffing plans and systems that provide for:
  • Evaluation of new protocols for feasibility and resource requirements.
  • recruitment procedures for potential participants.
  • active review of eligibility and recruitment of candidates for study participation.
  • Supervision and review of the ongoing informed consent process to ensure that research participants and their families have their questions answered and understand the patient/participant Bill of Rights, consent form, and participant's responsibilities in the study.
  • Review reported adverse events and insure timely reporting
  • Communication with participants throughout the study regarding pertinent updated study information.
  • Review of site nurse assessments of participants to ensure continued eligibility for participation in research.
  • Proactively supervises site staff regarding enrollment and follow-up of patients/participants for the trial (screening, randomization, data collection, study completion), and any study-related procedures as required by protocol.
  • Understand and proactively assess additional research activities to evaluate the safety and protection of research participants.
  • Utilize expert nursing and clinical trial knowledge of disease processes to review reported adverse events and protocol violations/deviations in a timely and accurate manner to the PI and Sponsor to ensure the health, safety, and welfare of the participants.
  • Collaborate with the PI to develop and implement corrective action plans for protocol violations.
  • Utilize expert nursing and clinical trial skills to complete research protocols (e.g., patient recruitment, screening, scheduling and organizing study visits, enrollment, laboratory and diagnostic studies, and study test article management).
  • Proactively identify and process complex clinical information under nursing scope of practice.
  • Oversee and/or perform the abstracting and recording of data from source documentation onto case report forms (paper or electronic) with attention to the requirements for accuracy, completeness, and timeliness.
  • Support the regulatory team in the maintenance and storage of critical documents required to be maintained and provided to the Sponsor during the conduct of the trial.
  • Plan, collaboratively lead, and participate in study team meetings, and develop and implement new data collection tools as appropriate.
  • Demonstrate comprehensive, in-depth research knowledge of policies, procedures, and regulations governing the protection of human subject research. If applicable, effectively prepare and process any IRB research submissions or work with the Regional Regulatory Support staff.
  • Establish and review SOPs ensuring that the site nursing staff communicate with participants regarding pertinent and/or new study information, and schedule and/or coordinate all protocol-specific appointments.
  • Oversee study completion, resolution of data queries, data lock, study closeout, and archiving of study files.
  • Ensure a communication plan is in place for changes to study file archiving.
  • Review procedures to ensure that any packaging and shipping of protocol specimens to the Sponsor lab are in accordance with IATA/DOT regulations, if applicable.
  • Support the effective financial management of the clinical trial.
  • Management of Staff:
  • In conjunction with CT administration, provide direct supervision of other licensed and non-licensed clinical trial research staff, if applicable.
  • An active participant with CT administration in selection and hiring of staff members.
  • Assure all staff receive appropriate orientation and training
  • Provide constructive performance feedback, timely performance reviews and, as needed, address staff performance problems promptly and in collaboration with CT adminstration.
  • Communicate staff needs and recommendations to PI and CT administration.
  • Positively influence team and share clinical nursing expertise.
  • Serve as educator, mentor, coach, role model, and expert resource to other research personnel.
  • Assume a key clinical nursing leadership role in research practice area.
  • Leadership and Communication
  • Expert clinical resource and content expert for troubleshooting complex, operational, and clinical issues within research program.
  • Communicate with internal and external parties, PI, Sponsor, clinical trials administrative management, KPSC IRB, study participants, and R&E Offices of Clinical Trial Compliance and Operations on an ongoing basis for compliance and operational needs, and provide reports, as appropriate.
  • Education and Training
  • Lead and provide site specific clinical trial new hire orientation, and act as direct supervisor and mentor for research personnel.
  • Create and implement protocol-specific education and training to appropriate personnel, including protocol- specific data collection tools developed for the research.
  • Actively identify and participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development as an expert nurse participating in the conduct of clinical trials.
  • Willingness to share expertise with KPSC clinical research colleagues either through research meetings, publications, professional posters, and/or professional national clinical trials presentations.
  • Proactively obtain and maintain nationally recognized clinical trial research professional organization certification (i.e., ACRP, etc.).
  • Attend KP site-initiated meetings for protocol training including Sponsor-initiated meetings, as requested.
  • Participate as a member of the Clinical Trial Operations Team and attend meetings as requested.
  • Quality Improvement
  • Actively participate in and implement site-specific quality improvement plan through ongoing assessment and evaluation, including staff adjustments and any additional training.
  • Recommend revisions to the quality improvement plan to PI and administrative management if additional safeguards or quality improvement issues are identified.
  • If applicable, develop and implement protocol-specific Standard Operating Procedures (SOP) to improve quality.
  • Business Impact:
  • Responsibilities can impact the achievement of local, regional, and national compliance and/or research program objectives assumed under the KP Federal-wide Assurance and various business contracts.
  • Responsibilities impact compliance with federal, state and local regulations and KP policies.
  • Failure to comply with regulations and KP policies may impact the research program objectives by potentially increasing financialrisk to KP, including the suspension of federal and other sources of funding Program wide. Erroneous decisions could result in the inability to reach functional objectives and may negatively affect the research program and the reputation of KP.
  • Functional/Technical Knowledge &Skills
  • Must be proficient in electronic healthcare systems and data bases used in research environment, or willingness to learn and demonstrate proficiency within six (6) months from hire.
  • Possess comprehensive clinical nursing knowledge and expertise in clinical trial research, and mastery of technical skills as well as pertinent regulations.
  • Demonstrate effective written, oral, and interpersonal communication skills.
  • Attention to detail and accuracy.
  • Ability to handle multiple tasks and deadlines.
  • Demonstrate prioritization and organizational skills.
  • Possess basic drug calculation knowledge and skills.
  • Demonstrate complex problem-solving skills.
  • Possess nursing skills (i.e. phlebotomy, performing vital signs, nursing assessments, etc.).
  • Other (specific to relevant therapeutic area).
  • Customer & Industry Knowledge:
  • In-depth knowledge of GCP, federal state, and local regulations including HIPAA and KP policies and procedures.
  • 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, as well as extensive clinical trialexperience in a specific therapeutic area.
  • Ability to work in a Labor Management Partnership environment.
  • Independence/Discretion:
  • Work with minimal supervision.
  • Must be self-directed and flexible.
  • Work is evaluated regularly upon completion and other internal/external parties to ensure objectives and performance requirements have been met; however, work independently a substantial amount of time.
  • Recognize and provide participants with research requirements under scope of practice and license.
  • Interactions/Communications:
  • Must maintain a culture of customer service by interacting and communicating professionally and effectively with internal and external parties.
  • Must have the ability to establish and maintain productive and supportive professional relationships and foster teamwork.
  • Must demonstrate professional verbal and written skills.
  • Problem Solving:
  • Must have the ability to solve complex problems with readily available solutions based on policies, expertise, and regulations, reporting problems to management (or others as appropriate) and seeking and offering expert consultation.
  • Accommodate unplanned events and respond with speed, efficiency, flexibility, expertise, and confidence.
  • Critically analyze research protocol and apply findings to practice.
  • Foster critical thinking and form mentoring relationships.
  • Recommend, implement, and evaluate practice changes based on evidence-based data.
  • Decision Making:
  • Make complex operational decisions independently adhering to policies, procedures, protocol, and all other regulations.
  • Act as a resource, mentor, and clinical expert in the decision-making process.
  • Ability to prioritize, delegate, and oversee others' quality and accuracy of research work.
  • Actively and positively influence team. Serve as a positive change agent.
  • Recommend, implement, and evaluate practice changes based on (published) research or policy and/or regulation changes.
  • Ability to troubleshoot complex issues in an ever-changing regulatory environment.

Basic Qualifications:

  • Minimum five (5) years of clinical nursing experience in a hospital, clinic or similar health care setting required.
  • Minimum five (5) years of clinical trials research experiencerequired.
  • Master's degree may be substituted for two (2) years work experience.
  • Minimum of a diploma from an accredited nursing school required.
  • Bachelor's degreerequired.
    License, Certification, Registration
  • Current CA RN license required.
  • Willingness to obtain other certifications, if required.

    Additional Requirements:
  • Effective project management skills required.
  • Previous team lead/staff supervisionexperiencerequired.
  • Must be able to work in a Labor/Management Partnership environment.

    Preferred Qualifications:
  • Previous experience in direct staff management preferred.
  • Specialization/certification in relelvant therapeutic area

  • Current ACRP or So CRA certification
  • Masters degree in Nursing or related field.