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.
Job Summary: Responsible for providing supervision, oversight, and quality control of Phase I clinical trial staff under the direction of the Vice President Clinical Trials Office. Responsible for the business development of the Phase I Clinical Trials Department and the integration of the department across various teams within the Karmanos and McLaren networks.
Responsibilities:
- Direct supervision of Phase I clinical trial staff. Evaluate staff performance with input from the Karmanos Vice President, Clinical Trials Office, the Medical Director – Phase I Clinical Trials, and other Management as applicable.
- Actively participates in the recruitment, hiring, discipline, and termination of Phase I clinical trial staff.
- Implements and maintains a Quality Assurance Program for Phase I clinical trial staff activities. This includes adherence to Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) guidelines, International Conference on Harmonisation (ICH) guidelines, and Good Clinical Practice (GCP) guidelines. Ensures compliance to both internal and external regulatory guidelines. Meets regularly with the Vice President, Clinical Trials Office, the Medical Director – Phase I Clinical Trials, Managers of various ancillary departments as needed in order to coordinate Phase I clinical trial activities with Karmanos CTO initiatives.
- Assists the Vice President, Clinical Trials Office, the Medical Director - Phase I Clinical Trials, and Phase I Medical/Grant Writers in providing clinical trials information for grant preparation and continuations as needed. Manages peer-reviewed grants.
- Responsible for business development of the Phase I Clinical Trials Office including setting and monitoring quality metrics, tracking clinical trial portfolio, managing feasibility reviews for incoming potential clinical trials, and working with sponsors to bring in new clinical trials.
Qualifications:
- Science based Bachelor’s degree required; Master’s degree in a health- or a science-related field preferred.
- Medical and/or science experience/education strongly preferred.
- Experience with scientific writing preferred.
- SOCRA or equivalent certification for at least 1 year required. If the candidate does not hold this certification, they must agree to obtain it within 2 years of hire.
- Minimum of two years prior management or supervisory experience including responsibility for hiring, training, discipline, and oversight of professional staff preferably in a clinical research setting.
- Minimum of five years of experience working in an oncology clinical trials setting at a research institution and/or pharmaceutical company.
- Experience working in Phase 1 oncology clinical research preferred.
- Demonstrated record of effectiveness in a management or supervisory position (clinic and/or administrative).
- Demonstrated leadership abilities and ability to analyze problems and affect resolution.
- Demonstrated ability to maintain cooperative working relations with internal and external units in a clinical research environment.
- Demonstrated ability to provide excellent customer service.
- Demonstrated initiative and attention to detail.
- Skilled in communicating sensitive/difficult information and maintaining highly confidential information.
- Proficient in computerized information systems and databases. Demonstrated expertise with the Microsoft suite.
- Knowledgeable in internal and external research regulations, GCP guidelines, Code of Federal Regulations, clinical trials monitoring, regulatory compliance, research budgets, etc.
Equal Opportunity Employer of Minorities/Females/Disabled/Veterans
Additional Information:
- Schedule: Full-time
- Requisition ID: 24001126
- Daily Work Times: TBD
- Hours Per Pay Period: 80
- On Call: No
- Weekends: No
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