York, PA | Professional | Tracking Code: 79434

Clinical Research Associate - York Hospital

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James Kane
James Kane
Sr. Talent Acquisition Consultant

Job Description:

Designs, coordinates and conducts designated research activities under the general supervision of the Research Director for the Department of Emergency Medicine, Wellspan York Hospital.  Provides related education, resources and consultation for staff members.  Manages a system for planning, organizing and controlling work flow of clinical studies approved for implementation in the Wellspan York Hospital Emergency Department.  Adheres to regulatory guidelines and insures timely, complete and accurate reporting of sensitive and confidential patient information.  Has regular contact with physicians, health care personnel and patients.  Assists resident and attending physicians with scholarly activity (Institutional Review Board (IRB) submission, presentations, manuscripts).


Duties and Responsibilities



1. Works collaboratively with and/or assists physicians, residents and related healthcare providers in the planning, coordinating, implementation and completion of research studies, clinical studies, multi-center clinical trials and other scholarly activities.


2. Assists principal investigators in preparing research protocols and consent forms and submitting required materials to the Institutional Review Board for pre-implementation review.  Coordinates the development and preparation of grant proposals to secure research funding.


3. Acts as a resource for researchers by providing literature searches, assistance in research design, coding and abstracting data, computer data entry, media production and IRB submission.


4. Assists researchers in preparing presentations and publications, as well as, contributing authorship to portions of manuscripts.


5. Ensures that research activities comply with safety, professional, organizational and federal standards and regulations.


6. Coordinates research activities in designated area and ensures efficient use of time, equipment, personnel and other resources to achieve objectives.


7. Works in collaboration with Research Director and research section to foster, support and expand undergraduate/student research associate program for the Department of Emergency Medicine.  Duties to include coordination, scheduling, oversight and education/didactics on the part of the Clinical Research Associate. 


8. Instructs students and novice researchers in proper research techniques and procedures.


9. Maintains a working knowledge of all research protocols.  Transmits and distributes protocol information, including protocol amendments, to the Institutional Review Board (IRB), physicians and staff members.  Serves as a senior non-medical resource for protocol and clinical research information.


10. Adheres to all protocol requirements to ensure validity of clinical research patient data.  Coordinates activities of clinical studies/trials and ensures adherence to the protocol by all personnel involved.


11. Collects or ensures that all pertinent and required data is properly abstracted and recorded on data collection forms for each study subject.


12. Creates and maintains patient database to ensure all data time points are captured.  Designs and distributes materials which aid physicians and other staff members in complying with protocol requirements and patient enrollment.


13. Meets regularly with principal investigators of studies to review data accuracy and overall study progress.  Identifies areas for improvement and initiates corrective action.


14. Prepares reports on individual patients as required by the study sponsor and/or the principal investigator.  Prepares and/or processes adverse event reports on patients enrolled in studies and submits to the principal investigator, the IRB, study sponsors and appropriate agencies.


15. Educates staff of affiliate departments as needed to conduct clinical trials and seeks to develop and maintain a working relationship with affiliates.


16. Prepares for and participates in audits of studies, both by internal and external parties.  In conjunction with the principal investigator, writes audit summary and reports and develops/coordinates corrective action plans as needed.


17. Under the direction of the principal investigator, prepares new study requests and protocol consent modifications to be sent to the IRB.  Prepares annual protocol renewal requests and termination reports for the principal investigator.


18. Ensures accurate receipt of payment from pharmaceutical, device or other sponsors, reconciling billable and received payments.


19. In collaboration with departmental principal investigators and Research Director, establishes and leads a process to pursue, review, vet and select clinical trials that are congruent with the vision/mission of the service line and that can be adequately supported by the program.




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


  • Minimum Experience:
    • 2 - 3 years of Clinical Research Experience


  • Minimum Education:
    • Bachelor's Degree


  • Minimum Field Of Expertise:
    • Clinical research 


  • Preferred Education:
    • Master's Degree


  • Skills:
    • Excellent organizational skills. Ability to follow multiple, detailed directions of various research protocols. Knowledge of medical terminology. Excellent oral and written communication skills. Ability to work independently. Comprehensive knowledge of clinical research principles, regulations and guidelines. Ability to assist in training and day- to-day oversight of subordinate personnel. Excellent computer skills including word processing, spreadsheet, relational database, project management, statistical and graphics software.
    • Training/experience in the responsible conduct of research, including medical/ research ethics and protection of the safety and welfare of human subjects in research.

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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.

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