York, PA | Professional | Tracking Code: 74471

Clinical Research Associate - Orthopedic Research - Days

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Anthony Jordan
Sr. Talent Acquisition Consultant

Full-Time Days

 

Job Description:

Under the general supervision of the Orthopedic Residency Program Director, designs, coordinates and conducts designated research activities and provides related education, resources and consultation for staff members.  Manages a system for planning, organizing and controlling workflow of clinical studies approved for implementation in the WellSpan Orthopedics Service Line.  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 physicians with required 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 and/or multi-center clinical trials, and other scholarly activities.
  2. 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.
  3. Assists researchers in preparing presentations and publications, as well as, contributing authorship to portions of manuscripts.
  4. Ensures that research activities comply with safety, professional, organizational and federal standards and/or regulations.
  5. Coordinates research activities in designated area and ensures efficient use of time, equipment, personnel and other resources to achieve objectives.
  6. Instructs students and novice researchers in proper research techniques and procedures.
  7. 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.
  8. 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.
  9. Collects or ensures that all pertinent and required data is properly abstracted and recorded on data collection forms for each study subject.
  10. 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.
  11. Meets regularly with principle investigators of studies to review data accuracy and overall study progress.  Identifies areas for improvement and initiates corrective action.
  12. Prepares reports on individual patients as required by the study sponsor and/or the principle investigator.  Prepares and/or processes adverse event reports on patients enrolled in studies and submits to the principle investigator, the IRB, study sponsors and appropriate agencies.
  13. Educates staff of affiliate departments as needed to conduct clinical trials and seeks to develop and maintain a working relationship with affiliates.
  14. Prepares for and participates in audits of studies, both by internal and external parties.  In conjunction with the principle investigator, writes audit summary and reports and develops/coordinates corrective action plans as needed.
  15. Under the direction of the principle 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 principle investigator.
 

 

Qualifications:

  • Minimum Experience:
    • 2 - 3 years
  • Minimum Education:
    • Bachelor's Degree
  • Minimum Field Of Expertise:
    • Clinical research or Nursing
  • 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.

Fraud Notice: Please be aware of potentially fraudulent job postings on other websites or suspicious recruiting email or text messages that attempt to collect your confidential information. If you are concerned that an offer of employment with WellSpan Health might be a scam, please verify by searching for the job posting on joinwellspan.org or contact us at employment@wellspan.org.


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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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