Job Description

PeaceHealth is seeking a Sys Dir Research & Clinical Trials for a Per Diem/Relief, 0.00 FTE, Day position. The salary range for this job opening at PeaceHealth is $0.00 - $0.00. The hiring rate is dependent upon several factors, including but not limited to education, training, work experience, terms of any applicable collective bargaining agreement, seniority, etc.

Job Summary

Directs, controls and is accountable for the Research and Clinical Trial activities within all PeaceHealth communities and facilities, including PHMG. This includes regulatory compliance of state and federal human research subject regulations including those required by CMS, FDA, OIG, and DHHS. Develops long and short-term business strategies, operational plans and oversees implementation. Manages the design, structure, development, and planning issues within scope of direction. Responsible for quality, service, and regulatory compliance for areas of responsibility including creation and implementation of policies, procedures, processes, and programs designed to meet regulatory requirements. Facilitates and leads implementation of efficient strategies, compliance with quality standards and patient satisfaction, financial planning and execution, recruitment, performance evaluation and staff training. Provides strategic leadership and day-to-day management for all aspects of human subject research across the organization. Provides leadership to the PeaceHealth System Institutional Review Board to support PeaceHealth's commitment to research. The Sys Dir Research and Clinical Trials must ensure that quality and performance improvement activities meet their target conditions. The Sys Dir Research and Clinical Trials is responsible to adhere to all applicable federal, state, and local laws, regulations, and standards for their areas and to be continuously ready for any survey on those regulations or standards.

Essential Functions

• Oversees the development, implementation, administration, and compliance of clinical trial operations related to PeaceHealth research activities. This includes the development, implementation and management of research policies, establishment and maintenance of an effective operational infrastructure, standard operating procedures, and oversight of patient care delivery activities associated with research studies.

• Works with key stakeholders including patient financial services ensures compliant research billing practices in alignment with CMS research billing regulations including the clinical trial national coverage determinations (NCD) and coverage with evidence (CED) considerations. Leads to assure integration of regulatory compliance in partnership with Organizational Integrity and Legal in PeaceHealth operations in order to comply and audit for Medicare billing and coding requirements. Promotes operational compliance through the use of standard tools and approaches through the optimization of the Research Module within the electronic patient record (CareConnect). Provides and educates to assure consistent interpretation and implementation of rules and regulations regarding specialized billing practices involving investigational products, emergency use authorizations, or other FDA application approvals.

• Coordinates with System Finance to develop budget and other financial measures and reports for the department. Works with sponsors, investigators, finance and legal counsel to oversee efficient negotiation of contracts/agreements, research budgets and research grants.

• Builds executive relationships with internal and external stakeholders and physician investigators to provide outstanding responsiveness and service to these constituencies, including support of research within identified service lines. Interfaces with sponsors and regulatory authorities.

• Provides leadership and direction to the research caregivers across the system in implementing best practice, standardizing workflow, and process redesign. Promotes collaboration and removes obstacles to effective teamwork. Facilitates constructive dialogue to resolve disputes.

• Provides oversight and support to the PeaceHealth System Institutional Review Board ensuring strict accordance with Federal guidelines regarding human subject research. Oversees protection of the rights and welfare of human subjects who participate in research; promotes the ethical principles of respect for person, beneficence and just; and ensuring compliance with the standards set forth in the Common Rule (45 CFR 46) by DHHS. Establishes expectations and disclosure requirements to ensure that conflicts of interest in research are identified, managed, or eliminated through development of policies and procedures that reflect the requirements of the US Public Health Service and the National Science Foundation.

• Ensures that there is adequate training, assistance, guidance and support to investigators, coordinators, IRB members, and other research support staff in matters related to regulatory compliance. Provides monitoring and quality assurance activities for ongoing research as needs are identified and assist investigators in the preparation for internal and external audits.

• Collaborates with Organizational Integrity in the development and execution of the clinical research compliance plan as part of the OI Clinical Compliance Program, Program Description and Work Plan according to 45 CFR 46 of the Code of Federal Regulations. Ensures the Research Compliance Plan addresses compliance with regulations published by the Office for Human Research Protections, the FDA, the Office for Civil Rights, the Office for Research Integrity, the Office of Management and Budgets, CMS and includes compliance with the ethical standards set forth in the Belmont Report.

• Collaborates with Organizational Integrity and legal counsel on the HIPAA Privacy Compliance Program to ensure research policies and activities address HIPAA and other state and federal laws applicable to the privacy and security of individually identifiable health information.

• Coordinates with System Finance for management and maintenance of Research Effort Reporting and Certification, and compliance with reporting requirements for federal grants according to 2 CFR Subtitle A (Office of Management and Budgets (OMB) Uniform Guidance for Grants and Agreements) and 2 CFR 200 (OMB Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).

• Performs other duties as assigned.

Qualifications

Education

• Bachelor's Degree Required: a combination of education and professional experience that provides the caregiver with the requisite knowledge, skills and abilities to successfully perform the job and

• Master's Degree Preferred: and

• Required: Nursing Roles: BSN or MSN required upon hire

Experience

• Minimum of 7 years Required: Experience related to clinical research and

• Minimum of 5 years Required: Related management experience

Skills

• Ability to deliver financial results for areas of accountability. (Required)

• Strong knowledge of FDA regulations and experience with IDE/HDE Trials. Knowledge of GCP. (Required)

• Demonstrated knowledgeable of hospital operations, billing and coding regulations and grant management. (Required)

• Excellent communication skills are required, both verbal and written. Able to communicate comfortably and effectively with regulatory authorities/sponsors/investigators. (Required)

• Demonstrated analytical and critical thinking skills. (Required)

• Ability to work in a collaborative manner. (Required)

• Proficient computer skills including MS Office applications. (Required)

• Demonstrated leadership ability. (Required)

Working Conditions

Lifting

• Consistently operates computer and other office equipment.

• Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.

• Sedentary work.

Environmental Conditions

• Predominantly operates in an office environment.

Mental/Visual

• Ability to communicate and exchange accurate information.

• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.

PeaceHealth is committed to the overall wellbeing of our caregivers. The benefits included in positions less than 0.5 FTE are 403b retirement plan for caregiver contributions; wellness benefits, discount program, and expanded EAP and mental health program.

See how PeaceHealth is committed to Inclusivity, Respect for Diversity and Cultural Humility.

For full consideration of your skills and abilities, please attach a current resume with your application. EEO Affirmative Action Employer/Vets/Disabled in accordance with applicable local, state or federal laws.

Job Tags

Daily paid, Full time, Temporary work, Work experience placement, Local area,

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