Mclaren Health Care Detroit , MI 48222
Posted 1 week ago
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:
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
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
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.
Mclaren Health Care