• Coordinate with research investigators and industry partners to assure that all the R&D activities of multiple NIH funded projects and contracts are in compliance with federal, state and university regulations and policies.
• Assist faculty in writing grant applications and contract proposals.
• Ensures necessary reviews of budget, salaries, and terms are met within deadlines.
• Negotiate and/or recommend modifications to contract/subcontract agreements.
• Assist in finding grant contract opportunities for faculty.
• May establish a database or other information resources.
• Position specifically responsible for managing compliance aspects of pre-clinical testing and evaluation of cardiovascular medical devices and developing standard operating procedures to assure all research activities are in compliance with Good Laboratory Practice for Nonclinical Laboratory Studies, NIH contract requirements and applicable FDA and USDA regulations.
• Ensuring proper completion and maintenance of technical files, study documents and records in accordance with guidelines.
• As appropriate, filing forms and reports for Human or Animal protections, the Office of Research and Development, and/or other campus entities.
• Identifying and tracking compliance issues to prompt and satisfactory resolution and participating on project teams and serving as the regulatory compliance expert on the team.
• Taking an active role in the development, management, and maintenance of the laboratory’s quality system and performing periodic internal laboratory audits to ensure continued compliance with internal and external requirements.
• Provide our partners with reports, records, and assistance to support preparation of regulatory submissions for US FDA, including 510(k)'s and IDE’s
• Lead the collection and management of study data and check the validity and accuracy of data ensuring compliance with quality control requirements.
• Participate in research activities related to data collection.
• Act as liaison with industry partners in manufacturing, quality assurance/quality control, and research and development to ensure that submission of pre-clinical data and reports are in accordance with FDA requirements and in accordance with International regulations and standards, where applicable.

• A BS degree, preferably in a scientific related field.
• 5 years of related experience; related experience would include background in medical device research and/or working knowledge of current FDA medical device regulations.
• One or more years of experience in Quality Assurance and Auditing in an animal laboratory or laboratory setting is preferred.
• For a unique combination of education and experience, validation of credit hours and experience may be considered.
• May require training related to occupational safety and health, environmental compliance, shipping of hazardous materials and/or ionizing radiation.
• Credit history review may be required.
• Bachelor’s degree in an unrelated field with at least 18 credits in a field related to the research of the clinic or laboratory, as appropriate, or Bachelor’s degree in unrelated field with at least one year of experience in a field directly related to the research of the clinic or laboratory, as appropriate.
• Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 college credits being equivalent to one year of experience.

• Knowledge of key practices in field as well as all established statutes, regulations, decisions, directives, and procedures.
• Thorough knowledge of MS Office Suite including a working knowledge of word processing and spreadsheet computer software packages.
• Ability to prioritize, plan, and execute multiple complicated and continuing contract and grant assignments in a timely manner.
• Ability to multi-task in a fast paced environment.
• Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications.
• Skill in acting as a liaison with internal clients to ensure timely and accurate submission of grants and contracts.
• Excellent oral/written communication and interpersonal skills

Clinical Research Nurse Project Coordinator, Kaiser Permanente, Duarte, California

Description:

Qualifications: BSN or BA/BS in related field (such as management, organization development, health services administration) required. Master's degree preferred. Graduate of accredited school of nursing. Current California RN license required. Significant experience (usually three (3) to five (5) years) in management and/or project management/operational planning. Previous experience with Kaiser Permanente preferred. Specific subject matter expertise in health care operations, care delivery and clinical processes. Demonstrated ability to conceive, plan and manage team based projects; knowledge of health care industry strategic business issues, with an understanding of KP, it's operations, social and legal environment; knowledge of Nurse Practice Act, JCAHO, and other local, state, and federal regulations.

Preferred Qualifications:

CCRP or CCRC certificate. Specific nursing expertise in bone marrow/stem cell transplantation, hematology/oncology care delivery and clinical processes. Three or more years experience in clinical research/clinical trials. Knowledge of MS word, excel and access.

Duties:

Provides leadership in redesign projects related to the coordination, design/redesign, delivery and management of nursing and patient care services. Identifies methods and approaches to reduce cost structures and maintain high quality of patient care.

Provides expertise on subject matter addressed by project team. Works with leadership and staff to implement programs. Recommends project strategy, identifies best methods and processes, develops project planning, group process facilitation, training, and appropriate application of information technology. Collaborates with stakeholders and sponsors to define project charter, framework, vision, and deliverables. Ensures quality and effectiveness of research. Monitors and maintains timelines and budget. Contracts with and manages work of internal/external consultants. Coordinates all internal and external communication, represents the project to internal and external group. Ensures the development of an effective implementation plan and facilitates the execution of this plan. Consistently supports compliance and the Principles of Responsibility (Kaiser Permanente's Code of Conduct) by maintaining the privacy and confidentiality of information, protecting the assets of the organization, acting with ethics and integrity, reporting non compliance, and adhering to applicable federal, state and local laws and regulations, accreditation and licenser requirements (if applicable), and Kaiser Permanente's policies and procedures. In addition to defined technical requirements, accountable for consistently demonstrating service behaviors and principles defined by the Kaiser Permanente Service Quality Credo, the KP Mission as well as specific departmental/organizational initiatives. Also accountable for consistently demonstrating the knowledge, skills, abilities, and behaviors necessary to provide superior and culturally sensitive service to each other, to our members, and to purchasers, contracted providers and vendors. Kaiser Permanente is an EEO/AA Employer.

Notes:

Liaison between Kaiser Permanente and City of Hope to coordinate cross-institutional communication, data collection and sharing, and long-term follow up of bone marrow/stem cell transplant patients on research protocols. Travel between institutions and to regional offices may be required.

This is a repost of WC.0801820.

Contact:

Web link:

http://kaiserext.kaiserpermanentejobs.org/joblist.html.

http://kp.taleo.net/careersection/external/jobdetail.ftl.