About Us
McLaren Health Care is a fully integrated health network committed to quality, evidence-based patient care with locations in Michigan and Indiana. The McLaren system includes 13 hospitals in Michigan, ambulatory surgery centers, imaging centers, a primary and specialty care physician network, commercial and Medicaid HMOs, home health, infusion and hospice providers, pharmacy services, a clinical laboratory network and a wholly owned medical malpractice insurance company. McLaren operates Michigan’s largest network of cancer centers and providers, anchored by the Karmanos Cancer Institute, one of only 53 National Cancer Institute-designated comprehensive cancer centers in the U.S.
Quality Assurance Specialist
Provides clinical trials auditing and
monitoring and follows established processes to support compliance according to
KCI Data and Safety Monitoring Plan (DSMP) and all applicable regulations.
Provides support for all facets of clinical trials auditing and monitoring with
special emphasis on institutional (investigator-initiated) and Cooperative
Group sponsored trials. This position is integral to the overall compliance of
clinical trial research and the protection of the rights and well-being of study
participants. Facilitates excellent
customer service and guidance in the clinical trial compliance arena. Ability
to manage independent assignments.
Responsibilities:
- Conducts a variety of compliance activities intended to facilitate and assure that clinical trials comply with the requirements of the protocol, the approving Institutional Review Board, Code of Federal Regulations, Good Clinical Practice, Food and Drug Administration (FDA), and KCI’s NCI approved Data and Safety Monitoring Plan.
- Conducts auditing and monitoring activities in accordance with established CTO policies and procedures.
- Activities may include: pre-study feasibility evaluations, ongoing monitoring of studies and study close-out, drug, device and correlative specimen compliance review.
- Reviews the accuracy, completeness and timeliness of study related records, and case report forms with original source documents.
- Reviews that study related processes relative to departmental guidelines and SOPs are in compliance.
- Bachelor’s degree and four plus years’ experience coordinating clinical trials: or equivalent combination of education/experience that includes at least five years in the clinical trials arena.
- Medical and/or science experience/education strongly preferred.
- Clinical research certification required for a minimum of one year.
- Clinical trial auditing and monitoring experience preferred.
- Proficient with the Microsoft suite including Excel and Power point.
- Exceptional interpersonal skills required and excellent verbal and written communication skills necessary to effectively deal with individuals both inside and outside the organization from diversified backgrounds.
- Skilled in communicating sensitive/difficult information and maintaining highly confidential information and situations.
- Demonstrated high level of interpersonal skills and analytical ability.
- Excellent writing and organizational skills.
- Demonstrated leadership abilities required.
- Demonstrated initiative and attention to detail.
Equal Opportunity Employer of Minorities/Females/Disabled/Veterans
Equal Opportunity Employer
McLaren Health Care is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identification, age, sex, marital status, national origin, disability, genetic information, height or weight, protected veteran or other classification protected by law.
