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Manager Clinical Research

Job ID 148379 Date posted 05/22/2018

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 patients? 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.


Minimum Qualifications:

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



About Lahey Health

At Lahey Hospital & Medical Center, as one of the world's premier health care organizations, we provide superior health care leading to the best possible outcome for every patient. We exceed our patients' high expectations for service each day. We also help advance medicine through research and the education of tomorrow's health care leaders

We care for our patients with compassion and openness, unsurpassed expertise, a drive for continuous learning improvement, and with respect, caring, teamwork, excellence and commitment to doing our personal best.

Join our team and our mission of excellence by applying today!

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