Manager - Research Clinical Operations

York, PA | Professional | Tracking Code: 72339

General Summary:

 

Under the supervision of the Corporate Director-WellSpan Research, the Clinical Research Operations Manager is responsible for implementation of clinical research operations system-wide.  Initially the role will be focused on restructuring clinical research staff roles to support a centralized model of research system wide.  Other responsibilities include overseeing and managing daily clinical research operations including, but not limited to, research nurse/research coordinator support, data management, lab specimen collection and processing, recruitment efforts, coordination with internal and external stakeholders, and research imaging and document management.  Future responsibilities will include assessing the system’s clinical research landscape to expand research activity across all service lines system wide.

 

Duties and Responsibilities:

 

  1. The Manager will be engaged in every aspect of patient care as defined in study protocol(s), leading the Clinical Operations teams from study feasibility assessment through execution.  
  2. The Manager will supervise clinical and administrative research personnel, assuring that each clinical trial meets patient care expectations and are conducted in accordance with the specific clinical protocol(s) and regulatory requirements.
  3. The Manager will engage and manage the performance of the Clinical Operations team and ensure that Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), Health Insurance Portability and Accountability Act (HIPAA), regulatory guidelines, and all best practices are followed rigorously. This includes development and preparation of Clinical Protocols, assuring that Investigator's Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs) are completed and followed.
  4. The Manager will create a cohesive work team that works collaboratively to achieve the research goals of the system. The manager will oversee the recruitment, performance, and training of team members and continually reviews strengths and weaknesses of staff to maintain a well-trained, highly engaged, and motivated team.
  5. Effectively interact with designated senior leaders, investigators, as well as, with external sponsors.
  6. Central to the position is ensuring compliance with external review organizations, most notably the Food and Drug Administration (FDA), Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP), Institutional Review Board (IRB), and the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).
  7.  In addition to clinical operations management, the Manager is responsible for working with the Manager of Research Business Services to establish the budget required to meet trial goals and for the allocation of financial resources to assure that the clinical trial(s) is executed fully.
  8. The Manager is also responsible for the development and implementation of innovative process ideas that impact clinical trials and/or clinical program management and to implement clinical operations quality systems, to ensure patient safety, document management, and quality control processes. This may include development of standard work, standard operating procedures (SOPs), training materials, and quality management activities.
  1. At all times the Manager is expected to remain actively engaged in organizational goals with particular focus on specific departmental and service line program goals and objectives.
  2.  Responsible for the design, development, implementation and maintenance of each clinical trial to ensure the allocation of fixed (personnel/space/equipment) and financial resources; establishing risk mitigation plans to ensure that all clinical trials are conducted in accordance with the study protocol.
  3. The Manager will work closely with those involved in the conduct of research at WSH, including HRPP Manager, Manager of Research Business Services, Research Program Manager, Corporate Compliance, and others, as applicable to meet the research goals of the system. This includes facilitating effective and timely communication between appropriate parties.
  4. Ability to manage change, promote positive interpersonal relationships, and has a well-established understanding of the healthcare culture. This includes excellent interpersonal and organization skills in dealing with physicians, staff, and others.

      

Qualifications:

  Note:                                   Other combinations of formal education, training and experience may be considered.

 

  Minimum Education             Bachelor’s  degree in a biological science or related field is required

 

  Preferred Education              Master’s degree in a biological science or related field is required

 

  Minimum Experience            Minimum of 5 years of experience in clinical care/clinical trials management

 

  Min Field of Expertise           Clinical Research Regulations, Regulatory Compliance, Management Skills,  Medical Terminology

 

  Required Certification            National certification related to clinical research or IRB administration (CCRC or CCRP)

 

  Pref Cert/Registration           CCRP or CCRC through a professional organization

                                       

  Skills: Other                         Advanced computer skills; excellent planning and organizing skills; Problem-solving skills; Strong administrative skills; excellent interpersonal/communication skills; excellent written and oral communication skills; ability to follow multiple, detailed directions of various research protocols; ability to work independently and to interpret related federal regulations; excellent computer skills including proficient in Microsoft Office applications. Adaptable to new software programs. Experience with IRB management systems.

 

Other                                    Training/experience in the responsible conduct of research, including medical/research ethics

                                             and protection of the safety and welfare of human subjects in research.  Experience in providing technical instructions to others. Experience in the conduct of Sponsored and Investigator Initiated research.

 

James Kane
James Kane
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Why WellSpan Health?

WellSpan Health is an integrated health system that serves the communities of central Pennsylvania and northern Maryland. The organization comprises a multispecialty medical group of more than 1,600 physicians and advanced practice providers, a regional behavioral health organization, a home care organization, eight respected hospitals, more than 20,000 employees and 200 patient care locations. WellSpan is a charitable, mission-driven organization committed to exceptional care for all, lifelong wellness and healthy communities. We are committed to transforming the health of the communities we serve and to educating the next generation of clinicians, staff and leaders.

Employment Benefits

  • Sign-on incentives for new employees (click here for details)
  • Medical, dental and vision insurance
  • Life and accidental death insurance
  • Supplemental life insurance
  • Retirement savings plan
  • Paid time off (PTO)
  • PTO bridging
  • Short-term disability
  • Educational assistance
  • Forgivable loan
  • Flexible spending
  • Credit union
  • Employee recreational activities
  • Childcare
  • Complimentary medicine discounts

Diversity & Inclusion

Welcome. Respect. Value.

Wellspan Health believes that diversity includes all the human characteristics that make each of us similar as well as different. We strive to make every person feel welcomed, respected, and valued while creating a safe and inclusive environment where we all have the individual freedom to express our uniqueness in a respectful manner.

WellSpan Health is an Equal Opportunity Employer. It is the policy and intention of the System to maintain consistent and equal treatment toward applicants and employees of all job classifications without regard to age, sex, race, color, religion, sexual orientation, gender identity, transgender status, national origin, ancestry, veteran status, disability, or any other legally protected characteristic. WellSpan Health does, however, have a tobacco-free/nicotine-free hiring policy.

Quality of Life

Founded in 1741, the city of York is considered by many as the first capital of the United States. The Articles of Confederation were signed by the Second Continental Congress here in 1777. Its beautifully restored historic district is an architectural treasure. While York retains its farming and manufacturing heritage, at its heart York is a thriving cultural community that has attracted creative talent and innovative entrepreneurial investors from across the nation.

Life in York County offers affordable housing, options for higher education, a thriving arts and cultural community, historical attractions, parks and recreational resources, semi-professional baseball team, fine dining and more — within an easy drive of major East Coast cities.

York County residents can find local employment in healthcare, manufacturing, technology, agricultural and service sectors. (Patient population: 445,000)