Job Description:
Manager, Clinical Research Program
Digestive Disease Institute
Seattle, WA
Full-time, 40 Hours/Week
Competitive Salary + DOE
Voted one of the top hospitals in Seattle, WA Virginia Mason Medical Center offers exciting opportunities in a team-oriented environment. Our multidisciplinary approach known as “Team Medicine” gives every individual the chance to contribute to the well-being of our patients and the continuing success of our medical center.
The Digestive Disease Institute at Virginia Mason is a nationally recognized leader in the multidisciplinary care of gastrointestinal disorders with strategic research and educational focus on pancreatic, liver, and esophageal disease. The Digestive Disease Institute seeks a Manager of Clinical Research to manage the overall conduct of clinical research at the Digestive Disease Institute (DDI), furthering the mission of DDI - to optimize patient care through innovations in research, education, and a multidisciplinary approach to treatment of digestive and liver diseases, and acting within the policies and procedures of Virginia Mason Medical Center and the Benaroya Research Institute. This position will work independently and with team members and leadership to ensure objectives are achieved, reporting to the Director and working in close partnership with the Director of Research.
PRINCIPAL ACCOUNTABILITIES
1. Strategically define, implement, evaluate and improve program vision, objectives, policies and procedures, ensuring adherence to ethical and regulatory standards. Collaborate with Director to implement strategic infrastructure to support high-quality clinical research conducted in a timely and efficient manner, emphasizing adaptability, flexibility, and staff/investigator satisfaction. Develop and implement policies and procedures to ensure clinical research is conducted in an ethical, fiscally sound manner and is compliant with all established local, state, and federal regulations.
2. Manage personnel, daily operations, and program finances.
Personnel. Identify core competencies and job responsibilities specific to staff positions and develop clear position descriptions and expectations. Hire, train, directly supervise, evaluate and, as needed, discipline and/or recommend termination of 12 staff members involved in clinical research activities. Determine, assign and manage staffing, training and coverage plans across all studies. Provide guidance to staff in the conduct of research and, as necessary, serve as back-up to staff to ensure activities are conducted in a timely manner. Ensure that all staff meet Fit for Duty requirements, including timely performance evaluations.
Daily operations. Lead and perform all pre-award/study initiation activities, including data collection and evaluation, feasibility review, budget development and analysis, coordination with internal and external staff, and IRB submission. With the Benaroya Research Institute, plan internal audits and implement improvement based results. Collect, maintain and analyze weekly, monthly and yearly metrics including patient visits and financials, evaluating data to assess initiation of a proposed new study and reporting to team and leadership. Assure cost effective daily operations.
Program finances. Create and maintain budgets for designated research programs and studies as well as overall budgets, financial metrics, and personnel effort allocation to ensure adequate funding and resources. As applicable, provide information to research sponsors/funders. Support review and negotiation of contracts and budgets in conjunction with contract specialist. Conduct detailed post-award financial management of all studies. Review financial monthly project reports, reconciling all studies with staff effort, contractual obligations/documents from the sponsor and internal software trackers. Facilitate sponsor payment.
3. Use the Virginia Mason Production System to remove waste and improve. Participate in improvement projects focused on achievement of annual goals and Virginia Mason Production System initiatives; ensure implementation of and adherence to improvement changes.
4. Represent DDI research to internal and external stakeholders. With investigators and sponsors, develop pipelines for clinical trial opportunities. Promote DDI’s research site to potential sponsors/external agencies. May assist in community outreach to promote research and increase study enrollment. Represent DDI research team at a variety of meetings within Virginia Mason Medical Center and the Benaroya Research Institute. Liaise with various departments and investigators to help fund, create, or oversee Investigator Initiated protocols. With Virginia Mason and Benaroya Research Institute, lead cross-institutional problem solving, change management and process improvement, and facilitate digestive disease research across multiple disciplines, departments and providers. May assist Principal Investigators regarding contractual obligations with sponsors/funders.
QUALIFICATIONS
Bachelor’s degree in a scientific discipline and at least four years of experience in a clinical research capacity, including at least two years of clinical research administration, supervisory or managerial experience. Proven organizational, team-building and problem-solving skills. Demonstrated ability exercise independent judgment and creativity and to effectively address complex administrative issues. Excellent written, verbal and interpersonal communication skills. Demonstrated competence in budget development, negotiation, analysis and management, and coordination and facilitation of substantive research through administrative means. Demonstrated experience coordinating projects involving diverse individual and institutional participants. Strong interpersonal skills in interactions with staff, leaders, sponsors/funders, investigators and regulatory agencies.
Preferred: Graduate and/or post-graduate degree a plus. Strong knowledge of medical terminology; and human subjects/ethics practices. Strong aptitude for detail. Advanced computer skills including Windows, Excel and Powerpoint. Ability to learn new program and computer systems specific to Virginia Mason and Benaroya Research Institute.
Equivalent education/experience may substitute for stated requirements.
Be a part of the Virginia Mason team where we offer you not only a competitive salary and comprehensive benefit package including relocation assistance, but also a wonderful place to live. Seattle, home to Virginia Mason, is a city that offers its residents the best of everything – from first-rate restaurants, shopping, and theatre to a wealth of recreation, outdoor activities and weekend getaways.
For more information about Virginia Mason’s Digestive Disease Institute or to apply online, visit our website at www.VirginiaMason.org. We are an equal opportunity employer.
*LI-VMMC
Manager, Clinical Research Program
Digestive Disease Institute
Seattle, WA
Full-time, 40 Hours/Week
Competitive Salary + DOE
Voted one of the top hospitals in Seattle, WA Virginia Mason Medical Center offers exciting opportunities in a team-oriented environment. Our multidisciplinary approach known as “Team Medicine” gives every individual the chance to contribute to the well-being of our patients and the continuing success of our medical center.
The Digestive Disease Institute at Virginia Mason is a nationally recognized leader in the multidisciplinary care of gastrointestinal disorders with strategic research and educational focus on pancreatic, liver, and esophageal disease. The Digestive Disease Institute seeks a Manager of Clinical Research to manage the overall conduct of clinical research at the Digestive Disease Institute (DDI), furthering the mission of DDI - to optimize patient care through innovations in research, education, and a multidisciplinary approach to treatment of digestive and liver diseases, and acting within the policies and procedures of Virginia Mason Medical Center and the Benaroya Research Institute. This position will work independently and with team members and leadership to ensure objectives are achieved, reporting to the Director and working in close partnership with the Director of Research.
PRINCIPAL ACCOUNTABILITIES
1. Strategically define, implement, evaluate and improve program vision, objectives, policies and procedures, ensuring adherence to ethical and regulatory standards. Collaborate with Director to implement strategic infrastructure to support high-quality clinical research conducted in a timely and efficient manner, emphasizing adaptability, flexibility, and staff/investigator satisfaction. Develop and implement policies and procedures to ensure clinical research is conducted in an ethical, fiscally sound manner and is compliant with all established local, state, and federal regulations.
2. Manage personnel, daily operations, and program finances.
Personnel. Identify core competencies and job responsibilities specific to staff positions and develop clear position descriptions and expectations. Hire, train, directly supervise, evaluate and, as needed, discipline and/or recommend termination of 12 staff members involved in clinical research activities. Determine, assign and manage staffing, training and coverage plans across all studies. Provide guidance to staff in the conduct of research and, as necessary, serve as back-up to staff to ensure activities are conducted in a timely manner. Ensure that all staff meet Fit for Duty requirements, including timely performance evaluations.
Daily operations. Lead and perform all pre-award/study initiation activities, including data collection and evaluation, feasibility review, budget development and analysis, coordination with internal and external staff, and IRB submission. With the Benaroya Research Institute, plan internal audits and implement improvement based results. Collect, maintain and analyze weekly, monthly and yearly metrics including patient visits and financials, evaluating data to assess initiation of a proposed new study and reporting to team and leadership. Assure cost effective daily operations.
Program finances. Create and maintain budgets for designated research programs and studies as well as overall budgets, financial metrics, and personnel effort allocation to ensure adequate funding and resources. As applicable, provide information to research sponsors/funders. Support review and negotiation of contracts and budgets in conjunction with contract specialist. Conduct detailed post-award financial management of all studies. Review financial monthly project reports, reconciling all studies with staff effort, contractual obligations/documents from the sponsor and internal software trackers. Facilitate sponsor payment.
3. Use the Virginia Mason Production System to remove waste and improve. Participate in improvement projects focused on achievement of annual goals and Virginia Mason Production System initiatives; ensure implementation of and adherence to improvement changes.
4. Represent DDI research to internal and external stakeholders. With investigators and sponsors, develop pipelines for clinical trial opportunities. Promote DDI’s research site to potential sponsors/external agencies. May assist in community outreach to promote research and increase study enrollment. Represent DDI research team at a variety of meetings within Virginia Mason Medical Center and the Benaroya Research Institute. Liaise with various departments and investigators to help fund, create, or oversee Investigator Initiated protocols. With Virginia Mason and Benaroya Research Institute, lead cross-institutional problem solving, change management and process improvement, and facilitate digestive disease research across multiple disciplines, departments and providers. May assist Principal Investigators regarding contractual obligations with sponsors/funders.
QUALIFICATIONS
Bachelor’s degree in a scientific discipline and at least four years of experience in a clinical research capacity, including at least two years of clinical research administration, supervisory or managerial experience. Proven organizational, team-building and problem-solving skills. Demonstrated ability exercise independent judgment and creativity and to effectively address complex administrative issues. Excellent written, verbal and interpersonal communication skills. Demonstrated competence in budget development, negotiation, analysis and management, and coordination and facilitation of substantive research through administrative means. Demonstrated experience coordinating projects involving diverse individual and institutional participants. Strong interpersonal skills in interactions with staff, leaders, sponsors/funders, investigators and regulatory agencies.
Preferred: Graduate and/or post-graduate degree a plus. Strong knowledge of medical terminology; and human subjects/ethics practices. Strong aptitude for detail. Advanced computer skills including Windows, Excel and Powerpoint. Ability to learn new program and computer systems specific to Virginia Mason and Benaroya Research Institute.
Equivalent education/experience may substitute for stated requirements.
Be a part of the Virginia Mason team where we offer you not only a competitive salary and comprehensive benefit package including relocation assistance, but also a wonderful place to live. Seattle, home to Virginia Mason, is a city that offers its residents the best of everything – from first-rate restaurants, shopping, and theatre to a wealth of recreation, outdoor activities and weekend getaways.
For more information about Virginia Mason’s Digestive Disease Institute or to apply online, visit our website at www.VirginiaMason.org. We are an equal opportunity employer.
*LI-VMMC