Acumed
  • 30-Sep-2019 (PST)
  • Clinical Studies
  • Hillsboro, OR, USA
  • DOE
  • Salary
  • Full Time
  • Worksite - Cornelius Pass

Medical, Vision, Dental, 401(k) match, Paid Parental Leave, Paid Time Off, Floating Holidays, Tuition Reimbursement Program, TriMet Pass, Costco Membership, Summer Hours and more!


About Us

Acumed is a global leader of innovative orthopaedic and medical solutions developed to improve patient care. With over three decades of experience in the orthopaedic industry, our mission is to aid the afflicted through the ingenuity of our minds, the labor of our hands and the compassion of our hearts. The company is headquartered in Hillsboro, Oregon with a global sales and distribution network supported by offices worldwide.

Clinical Research Specialist

The Clinical Research Specialist (CRS) is responsible for the facilitating assigned research studies in accordance with established procedures and regulations.  The CRS executes strategies for pre- and post-market clinical studies and facilitates operational and logistical tasks to ensure efficient clinical trials.  Collaborates with Director, Clinical Studies, Product Management, and Business Services  to ensure study activities occur in compliance with the appropriate regulations, including Food and Drug Administration (FDA) regulations, Investigational Device Exemption (IDE), 510 (k) guidelines, etc.  The CRS coordinates resources for patient recruitment, trial site selection, and execution of trials with a focus on quality.  The CRS provides on-going administrative assistance in the management of funded research studies.


Duties/Responsibilities

  1. Facilitates and tracks compliance of review process to ensure Acumed and Investigator-initiated research projects are ethical, medically relevant, and scientifically valid.
  2. Serves as internal and external point of contact for daily activities of assigned Acumed or investigator-initiated research.
  3. Administers site compensation on assigned projects, ensuring compliance and deliverables are met.
  4. Assists with monitoring and reporting metrics on assigned studies to assess research performance, including publication tracking, study status, invoicing, product disposition, speed and effectiveness of contracting, start-up, training, recruitment, protocol adherence, data collection and reporting.
  5. Interfaces with investigators, clinical site personnel, Clinical Research Organizations (CROs), Institutional Review Boards (IRBs), and appropriate company personnel as required regarding research projects.
  6. Collaborates with Product Management, Regulatory and Compliance team members to ensure research needs are met.
  7. Performs clinical trial site visits as needed to ensure regulatory and study compliance.
  8. Collaborates with other team members to coordinate the development and finalization of key study documents.
  9. Contributes to the development of relevant standard operating procedures.
  10. Assists with pre-meeting activities to support the monthly Research Review Committee (RRC) meetings.
  11. Records RRC meeting minutes and prepares draft minutes.
  12. Oversees and manages study product disposition.
  13. Tracks and reports relevant Sunshine Act requirements for research studies (financial and product).
  14. Creates POs and processes department invoices.
  15. Additional duties as assigned.

Qualifications

  1. BS or BA in Quality Assurance, Regulatory Affairs, Clinical Research or related field required; focus in biological science or research or equivalent preferred. Advanced degree preferred.
  2. Minimum 1-3 years of experience in Clinical Research.
  3. Demonstrated awareness and understanding of positive ethical and moral principles consistent with clinical research and the mission and values of the organization.
  4. Knowledge of FDA and International Conference on Harmonization (ICH) regulatory requirements and general clinical research operations.
  5. Demonstrated independent judgment and decision-making skills with respect to functional responsibilities.
  6. Motivated to optimize clinical operations processes to meet deliverables.
  7. Ability to effectively work with teams and promote collaboration.
  8. Excellent verbal and written communication skills
  9. Adaptable to changing environments.
  10. Able to work in a fast-paced environment.
  11. Independently manages multiple projects simultaneously.
  12. High level of proficiency in MS Office.

Preferred qualifications

  1. Medical device clinical research experience
  2. Orthopedic research experience
  3. Clinical Research experience from the Sponsor perspective
  4. ACRP or SOCRA certification

 

Acumed and ACUTE are equal opportunity employers. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.

As an equal opportunity employer, Acumed is committed to providing reasonable accommodations to applicants with disabilities. If you are interested in applying to Acumed and need special assistance or accommodation, please contact us at recruiting@acumed.net.

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