Address
Form of work
SalarySchedule:
Full time - 36 hours/week or greater Shift:
First Shift (Days - Less than 12 hours per shift) (United States of America) Weekly Work Schedule:
M-F, 8-5 Job Information
Exemption Status: Exempt
A Brief Overview
The Clinical Research CenterProgram Manager (PM) is responsible for leading the quality performance of the Center. The PM serves as a liaison between various principal investigators (physicians and advance practice providers), research sponsors, contract research organizations, research vendors, and organizational departments and team members. The primary focus of the PM is to plan, organize, supervise and motivate team members to ensure the effective and efficient delivery of Clinical Research enrollment, retention and quality outcomes. The PM is the lead project manager for their assigned panel of research studies, providing strategic planning, operational oversight, and ensuring the Research Program reaches its annual goals and effectively serves its mission. The PM is responsible for various strategic priorities throughout the Center. The delivery of professional nursing care at Stormont-Vail HealthCare is guided by Jean Watson's Theory of Human Caring and the theory of Shared governance, both of which are congruent with the mission, vision, and values of the organization.
Education Qualifications
Exemption Status: Exempt
A Brief Overview
The Clinical Research CenterProgram Manager (PM) is responsible for leading the quality performance of the Center. The PM serves as a liaison between various principal investigators (physicians and advance practice providers), research sponsors, contract research organizations, research vendors, and organizational departments and team members. The primary focus of the PM is to plan, organize, supervise and motivate team members to ensure the effective and efficient delivery of Clinical Research enrollment, retention and quality outcomes. The PM is the lead project manager for their assigned panel of research studies, providing strategic planning, operational oversight, and ensuring the Research Program reaches its annual goals and effectively serves its mission. The PM is responsible for various strategic priorities throughout the Center. The delivery of professional nursing care at Stormont-Vail HealthCare is guided by Jean Watson's Theory of Human Caring and the theory of Shared governance, both of which are congruent with the mission, vision, and values of the organization.
Education Qualifications
- Associate's Degree Associate's Degree of Nursing Science (ADN). Required
- Bachelor's Degree Bachelor's of Science in Nursing (BSN). Preferred
Experience Qualifications
- 5 years Clinical research experience. Required
Skills and Abilities
- Ability to communicate effectively using verbal, non-verbal and written methods. (Required proficiency)
- Ability to perform mathematical calculations related to medication administration and equipment calibration. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. (Required proficiency)
- Ability to identify, assess and resolve problems. (Required proficiency)
- Willingness to learn necessary computer skills including but not limited to: Epic electronic health record, Microsoft Office, web-based databases and repositories, and other research protocol specific electronic systems. (Required proficiency)
Licenses and Certifications
- Association of Clinical Research Professional - Certified Professional (ACRP-CP) - ACRP Certification from an accredited association of Clinical Research professionals is required, such as the Association of Clinical Research Processionals (ACRP), the Society of Clinical Research Processionals (SoCRA), or equivalent industry organization. Required
- Registered Nurse - KSBN Required
What you will do
- Research Program Leadership: Develop Clinical Research panels ensuring adequate volume of studies, appropriate therapeutic areas, and procurement of trials that benefit the program, patients and the area population. Manage site feasibility surveys and site-screening visits, developing systems to respond efficiently and effectively. Manage study assignments to coordinators, investigators and sub-investigators. Identify growth opportunities, utilizing various methods including investigator databases/platforms, industry outreach, web searches, and other targeted marketing efforts.
- Productivity Leadership: Manage team members to achieve protocol and department enrollment goals, developing strategies for subject identification, recruitment, and overall project management. Work with the Director to implement and manage action plans required to reach department goals. Manage department Performance Excellence projects, ensuring alignment with priorities, effective implementation and long-term adoption Serve as back-up and unblinded Clinical Research coordinator.
- Research Knowledge: Demonstrate expertise in research regulations and areas of interest, including but not limited to: International Code of Harmonization-Good Clinical Practice (ICH-GCP), Food and Drug Administration, SVH policies and procedures and Cotton O’Neil Clinical Research Center Standard Operating Procedures. Attend protocol-specific and industry meetings as assigned. Propose topics for policy development, standard operating procedure improvement, quality compliance and growth. Serve as a mentor for team members, including protocol management, recruitment, compliance and communications.
- General Supervision of Team Members: Mange staff (to include research component of advance practice providers), requests for time off and other benefits. Approve time recordings at each pay period. Conduct team meetings, ensuring appropriate communications, recording and follow-up. Assist with planning and presentations at monthly Learning Forum department meetings. Assist with day-to-day operations of site and staff. Deliver staff corrective action as required. Complete evaluations of staff performance. Mentor new and tenured team members
- Research Excellence: Maintain on-going familiarity with quality of research protocol management. Assist with research protocol quality audits and follow-up. Facilitate effective use of Clinical Trial Management System. Assist in development and/or review of protocol source documentation worksheets. Ensure overall organization of research units, i.e. temperature monitoring compliance, cleanliness, order, and inventory. Review Subject ID logs to ensure SOP compliance. Review regulatory binders, subject charts, and other records to ensure compliance, to identify process improvement opportunities, and to identify training needs. Meet with Clinical Research Associates/monitors to assess performance, to develop strong collaborations, and to identify future prospects. Marketing, increasing overall awareness of Clinical Research Center. Serve as representative of Clinical Resort center in various organizational and community groups and activities.
- Fiscal Stewardship: Assists the Director with implementation and management of various fiscal initiatives. Assists with data collection and analysis efforts. Promotes recruitment and program growth to ensure fiscal goals are achieved. Promotes timely use of Clinical Conductor and contributes to utilization of this Clinical Trial Management System for department analytics and strategic planning.
- Maintain SVHC Competencies: Maintain SVHC competency on all procedures required for Clinical Research protocol execution, such as ECG, point of car testing, vital signs, or other protocol-specific procedures. Coordinate, supervise, and engage in direct patient/subject care associated with and during various Clinical Research protocols, including conducting ECGs, vital signs. Maintain any required training and credentialing. Maintain current curricula vitae. Sign-off on knowledge at time of employment and during annual competencies.
Required for All Jobs
- Complies with all policies, standards, mandatory training and requirements of Stormont Vail Health
- Performs other duties as assigned
Patient Facing Options
- Position is Patient Facing
Remote Work Guidelines
- Workspace is a quiet and distraction-free allowing the ability to comply with all security and privacy standards.
- Stable access to electricity and a minimum of 25mb upload and internet speed.
- Dedicate full attention to the job duties and communication with others during working hours.
- Adhere to break and attendance schedules agreed upon with supervisor.
- Abide by Stormont Vail’s Remote Worker Policy and will review and acknowledge the Remote Work Agreement annually.
Remote Work Capability
- Hybrid
Scope
- Has Supervisory Responsibility
- No Budget Responsibility No Budget Responsibility
Physical Demands
- Balancing: Occasionally 1-3 Hours
- Carrying: Frequently 3-5 Hours
- Climbing (Ladders): Rarely less than 1 hour
- Climbing (Stairs): Occasionally 1-3 Hours
- Crawling: Rarely less than 1 hour
- Crouching: Occasionally 1-3 Hours
- Driving (Automatic): Occasionally 1-3 Hours
- Driving (Standard): Occasionally 1-3 Hours
- Eye/Hand/Foot Coordination: Frequently 3-5 Hours
- Feeling: Occasionally 1-3 Hours
- Grasping (Fine Motor): Frequently 3-5 Hours
- Grasping (Gross Hand): Frequently 3-5 Hours
- Handling: Frequently 3-5 Hours
- Hearing: Frequently 3-5 Hours
- Kneeling: Occasionally 1-3 Hours
- Lifting: Frequently 3-5 Hours up to 15 lbs
- Operate Foot Controls: Occasionally 1-3 Hours
- Pulling: Frequently 3-5 Hours up to 15 lbs
- Pushing: Frequently 3-5 Hours up to 15 lbs
- Reaching (Forward): Frequently 3-5 Hours up to 15 lbs
- Reaching (Overhead): Frequently 3-5 Hours up to 15 lbs
- Repetitive Motions: Frequently 3-5 Hours
- Sitting: Occasionally 1-3 Hours
- Standing: Frequently 3-5 Hours
- Stooping: Occasionally 1-3 Hours
- Talking: Occasionally 1-3 Hours
- Walking: Frequently 3-5 Hours
Working Conditions
- Chemical: Rarely less than 1 hour
- Combative Patients: Rarely less than 1 hour
- Dusts: Occasionally 1-3 Hours
- Extreme Temperatures: Rarely less than 1 hour
- Infectious Diseases: Rarely less than 1 hour
- Mechanical: Rarely less than 1 hour
- Needle Stick: Rarely less than 1 hour
- Noise/Sounds: Occasionally 1-3 Hours
- Other Atmospheric Conditions: Rarely less than 1 hour
- Risk of Exposure to Blood and Body Fluids: Rarely less than 1 hour
- Risk of Exposure to Hazardous Drugs: Rarely less than 1 hour
- Hazards (other): Rarely less than 1 hour
Stormont Vail is an equal opportunity employer and adheres to the philosophy and practice of providing equal opportunities for all employees and prospective employees, without regard to the following classifications: race, color, ethnicity, sex, sexual orientation, gender identity and expression, religion, national origin, citizenship, age, marital status, uniformed service, disability or genetic information. This applies to all aspects of employment practices including hiring, firing, pay, benefits, promotions, lateral movements, job training, and any other terms or conditions of employment.
Retaliation is prohibited against any person who files a claim of discrimination, participates in a discrimination investigation, or otherwise opposes an unlawful employment act based upon the above classifications.
