Job Overview
MUST HAVE PHLEBOTOMY EXPERIENCE
We are seeking a dynamic and highly organized Site Manager / Lead Clinical Research Coordinator to oversee the planning, execution, and management of clinical trials at our Detroit, Michigan research site.
This pivotal role involves leading a team of research professionals, ensuring compliance with regulatory standards, and maintaining the highest standards of data quality and patient care. The ideal candidate will possess strong leadership abilities, extensive clinical research experience, and a passion for advancing healthcare through meticulous project management.
Join our Detroit team and make a meaningful impact on medical innovation while fostering a collaborative, compliant, and patient-centered research environment.
Responsibilities
- Lead and supervise the clinical research team, including clinical research coordinators, nurses, and support staff, to ensure efficient daily site and trial operations.
- Oversee patient recruitment, screening, informed consent, enrollment, and ongoing monitoring to ensure participant safety and adherence to study protocols.
- Manage study documentation, source document review, data collection, and data management in accordance with Good Clinical Practice guidelines and applicable regulatory requirements.
- Ensure compliance with FDA regulations, ICH GCP standards, HIPAA privacy requirements, institutional policies, and study-specific procedures.
- Coordinate with sponsors, contract research organizations, regulatory bodies, investigators, and internal teams to support study start-up, monitoring visits, audits, inspections, and closeout activities.
- Maintain complete and accurate trial records using electronic medical record systems, clinical trial management systems, electronic data capture platforms, and other data-management tools.
- Review source documents and study data for accuracy, completeness, consistency, and timely entry.
- Conduct regular staff training on clinical trial protocols, ethical guidelines, safety procedures, blood sampling, vital-sign measurement, and documentation standards.
- Monitor staff performance, delegate responsibilities, and provide ongoing coaching and operational support.
- Support quality-assurance activities and implement corrective and preventive actions when necessary.
- Maintain site readiness for sponsor monitoring visits, audits, and regulatory inspections.
Requirements
- At least two years of clinical research experience.
- At least two years of phlebotomy experience.
- At least one year of mental health research experience.
- Previous supervisory or leadership experience in a clinical research or healthcare environment.
- Strong knowledge of medical terminology, clinical laboratory procedures, blood-sampling techniques, phlebotomy, and vital-sign assessment.
- Thorough understanding of FDA regulations, ICH GCP guidelines, CDISC data standards, HIPAA requirements, and healthcare compliance practices.
- Current Good Clinical Practice certification.
- Experience with clinical trial management systems, electronic medical record systems, electronic data capture platforms, statistical or data-analysis software, and Microsoft Office.
- Demonstrated ability to review complex study documentation accurately while maintaining exceptional attention to detail.
- Excellent project-management and organizational skills, with experience coordinating research projects from study start-up through closeout.
- Knowledge of clinical research ethics, participant protection requirements, and quality-assurance standards.
- Strong written and verbal communication skills.
- Ability to manage competing priorities, meet deadlines, and work effectively with sponsors, investigators, staff, and study participants.
- A nursing or healthcare-related background is preferred.
- Clinical laboratory experience is highly desirable.
Benefits
- 401(k)
- Dental insurance
- Health insurance
- Retirement plan
- Vision insurance
Experience
- Clinical research: 2 years required
- Phlebotomy: 2 years required
- Mental health research: 1 year required
Location
- Detroit, MI — required
- Work Location: In person at our Detroit research site
Join us in advancing groundbreaking medical research and leading projects that improve lives. We are committed to creating an inclusive workplace where your expertise can thrive while making a tangible difference in healthcare innovation. This is a paid position with opportunities for continued professional growth within a vibrant research community.
Pay: $30.00 - $38.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Vision insurance
Work Location: In person
