Location: Burlington, MA
Job ID: 148379-1A
Date Posted: Dec 4, 2019
Category: Clinical Professional
Lahey Hospital & Medical Center is part of a vibrant and growing health care system, recognized as a trailblazer in medicine and a standard bearer in patient experience. It includes an award-winning academic medical center, a superb constellation of community hospitals, home care services, rehabilitation facilities and more.
We are committed to attracting, developing and retaining top talent in a market long recognized and revered as a global leader in health. With a team approach to care, we encourage learning and growth at all levels, and we offer competitive salaries and benefits. We adhere to the principles of a just and fair work environment for all colleagues, where respect is foundational and performance is rewarded.
About the Job
As an integral part of the leadership infrastructure of Research Administration, the Clinical Research Manager is responsible for implementing the mission of the Department by overseeing the day to day conduct of Clinical Research Associates and Research Nurses to ensure that clinical research activities are performed in a manner consistent with Lahey, FDA, and IRB guidelines. The role includes participating in the development, implementation, evaluation and revision of procedures to maximize efficiency, safety and productivity, and acting as a resource for investigators and study coordinators to assess organizational factors involved in the implementation and conduct of all studies including staff resources, technology, documentation requirements, and practical aspects. This position reports to the Director of Research Administration.
Essential Duties & Responsibilities including but not limited to:
1. Provide direct supervision for up to 10 Clinical Research Associates and Research Nurses in the Research Administration Clinical Research Support Office, and Cancer Center.
2. Ensure adequate CRA/nursing coverage of all studies and provide coverage as needed.
3. Serves in the role of a CRA when needed, including coordinating all aspects of individual clinical studies. This may include providing direct patient care (if licensed or certified to do so), such as performing phlebotomy, assessing vital signs, and educating patients on study protocol risks and requirements. CRA duties also include recruiting patients to participate in studies, and completing all administrative paperwork and data entry related to studies. Provide leadership and supervision based on existing departmental and organizational procedures and policies to guide research center staff in the implementation of clinical research studies. Monitors compliance with Federal (FDA, OHRP), State and institution regulations and SOPs relating to clinical research.
4. Assist, support and supervise staff in attaining departmental and institutional required competencies, training, and certifications, and perform general supervisory functions to facilitate adherence to safe practice in the conduct of clinical research.
5. Make recommendations to the Director on needs of the team to ensure maximum productivity, efficiency and patient safety, such as educational and support services required for staff to perform their job and/or recommendations regarding resources needed for new studies.
6. Develop, implement and support systems to promote efficiency and productivity, such as shared files/schedules, tracking system for IRB renewals, and operating systems to economize resources.
7. Facilitate integration of regulatory issues to ensure safe practice.
8. Provide leadership, guidance and expert advice in the areas of standard operating procedure (SOP) development, developing and maintaining research files and case report forms (CRFs) in accordance with current regulations.
9. Promote collaboration and a work environment conducive to team work and employee satisfaction.
10. Develop and provide staff with tools to assist in the orientation to Research Administration specific training such as center specific Resource Manual and/or checklists
11. Provide assistance to research center staff in their daily work related to prioritizing projects and tasks.
12. Collaborate with PIs and study team on new studies to ensure timely start up, and be available to assist study team with coordination of services needed to implement the study, available to assess study progress and problem solve as needed.
13. Promote forums for communication of information and opportunities for team discussion and problem solving by scheduling staff meeting and other meetings as needed.
14. Represent the department in hospital and other forums and interact with sponsors.
15. Collaborate with team members in the development of new research studies in the role of coordinator.
16. Provide project management for enhancement of services and processes
17. Evaluate current operational practices and recommend process improvements to ensure continued compliance with regulatory requirements and institution expectations.
18. Keeps up to date with current research regulations and institution SOPs.
19. Responsible for reviewing draft prospective reimbursement analyses and budgets, and assisting in the coverage analysis and budgeting process for clinical trials.
20. Responsible for ensuring regular review of patient care charges related to patient’s participation in clinical trials
21. Assist research staff with patient care charge reconciliation.
22. Responsible for training research staff on the review and reconciliation of patient care charges.
23. Assist with invoicing sponsor for invoiceable items in conjunction with Research Finance.
Education: Bachelors degree. Nursing or other clinical degree preferred. Masters degree also preferred.
Licensure, Certification & Registration: Certification by SoCRA (the Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) preferred.
Experience: Eight years experience with a Bachelor’s degree, five years with a Master's degree of related experience in clinical research administration, and demonstrated experience in clinical research processes in an academic institution
Skills, Knowledge & Abilities:
- Progressively responsible experience in managing all aspects of clinical research study implementation and conduct
- Sound judgment, ability to delegate and prioritize, assist others with prioritizing study tasks
- Ability to analyze complex situations and implement problem solving skills
- Experience in training and education
- Strong planning, time management and organizational skills
- Good interpersonal skills, multi- tasking abilities to handle many projects and responsibilities at once
- Works collaboratively with others
- Demonstrated initiative and leadership skills, interest and enthusiasm for change, willingness to take on new challenges
- Sound knowledge of principles of SOPs, GCP, FDA, IRB, clinical research methodology, regulations, and compliance
- Demonstrated ability to lead discussions/meetings, and obtain cooperation and support from team
- Commitment to ongoing learning to produce safe, effective, quality outcomes,
- Ability to work effectively and collaboratively with a wide range of staff and interdisciplinary teams
- Works independently with guidance from the Director
- Values diversity, integrity and confidentiality; professional demeanor and ability to represent Lahey in public venues
The Lahey Model of Care—right care, right time, right place—is exactly what patients, providers and payers need and deserve. Identifying and delivering on this convergence of interests has positioned Lahey Health for further growth. Our model ensures care is highly coordinated and locally delivered, with lower costs and exceptional quality.
Lahey Health is a robust, regional system including a teaching hospital, community hospitals, primary care providers, specialists, behavioral and home health services, skilled nursing and rehabilitation facilities, and senior care resources throughout northeastern Massachusetts and southern New Hampshire. The system has a global presence with programs in Canada, Jordan and Bermuda.
Equal Opportunity Employer/Minorities/Females/Disabled/Veterans.