Clinical Research QA Education Project Manager

Job Description

This role sits within the Quality team supporting the Cancer, Clinical Trials and Translational Research Office and focuses on designing, delivering, and overseeing education and training for research staff.

The specialist ensures all team members complete required training and remain compliant with regulatory and institutional standards, while also creating new training content that supports high-quality clinical research and patient care.

The position works closely with a multidisciplinary department that includes research assistants, regulatory staff, clinic and data coordinators, nurses, and administrative functions such as contracts.

Responsibilities

• Develop, deliver, and maintain comprehensive education and training programs for clinical research staff within the cancer and translational research office.
• Monitor and ensure completion of required training by all relevant employees, verifying ongoing compliance with institutional and regulatory requirements.
• Create new training content, materials, and resources that address evolving regulatory requirements, protocol changes, and best practices in clinical research and patient care.
• Support and educate staff on protocol review and execution, including treatment-focused clinical trials (not observational studies), ensuring adherence to study requirements.
• Oversee and reinforce proper documentation practices, including accurate and timely recording of research activities, patient interactions, and regulatory submissions.
• Maintain and manage schedules of adherence for training, audits, and protocol-related activities, ensuring all deadlines and milestones are met.
• Collaborate with research assistants, regulatory personnel, clinic coordinators, data coordinators, nurses, and administrative staff to align training with site workflows and operational needs.
• Provide guidance on regulatory processes and compliance, helping staff understand relevant regulations and how to interpret and apply them in daily work.
• Lead or support educational sessions on regulatory updates, institutional policies, and sponsor requirements to promote consistent, compliant practices.
• Participate in preparation for sponsor, internal, and FDA audits, including organizing documentation, training records, and evidence of compliance.
• Contribute to audit readiness efforts by identifying training gaps, implementing corrective education, and reinforcing quality standards.
• Collaborate with leadership and peers to continuously improve training programs based on audit findings, feedback, and changes in clinical research standards.
• Support initiatives that enhance quality and safety in oncology clinical trials, indirectly contributing to improved patient care.
• Engage with colleagues across the department to share best practices and promote a culture of continuous learning and quality improvement.
• Explore opportunities to expand responsibilities or move into other roles within the department, contributing to broader quality and educational initiatives.

Essential Skills

• At least five years of experience in clinical research, with exposure to all aspects of research, including patient care, data management, and regulatory processes.
• Hands-on experience with clinical trials, specifically treatment protocols rather than observational studies.
• Strong understanding of clinical research operations, including protocol review, execution, documentation, and site workflows.
• Demonstrated experience in regulatory compliance within a clinical research or clinical trials environment.
• Ability to understand, interpret, and apply regulations to research practice, and to educate or train others on these regulations.
• Experience participating in sponsor, internal, or FDA audits related to clinical research.
• Experience in clinical research training and education, including developing and delivering training content.
• Clinical research certification or equivalent professional credential in clinical research.
• Experience working in oncology clinical research settings.
• Solid patient care experience in a research or clinical environment.
• Strong communication skills, with the ability to explain complex regulatory and clinical concepts clearly to diverse research staff.
• Attention to detail and organizational skills necessary to manage training schedules, documentation, and audit preparation.
• Additional Skills & Qualifications
• Experience in oncology-focused clinical trials, particularly treatment protocols, is highly desirable.
• Prior involvement in training design, content creation, and audit preparation in a research environment.
• Familiarity with cancer center operations and workflows across research assistants, regulatory staff, coordinators, nurses, and administrative teams.
• Demonstrated ability to collaborate effectively with multidisciplinary teams in a clinical research setting.
• Interest in career growth within the quality, education, or clinical research domains, with openness to exploring new opportunities within the department.
• Comfort with balancing both in-person and remote work while managing schedules dependent on meetings, audits, and departmental activities.

Work Environment

The position is based within a cancer-focused clinical trials and translational research office located in a modern clinical and research facility.

The specialist works closely with one other coordinator and a manager as part of a small, collaborative Quality team.

The role follows a hybrid schedule, requiring onsite presence two days per week and remote work for the remaining three days.

Onsite days vary from week to week depending on meetings, audits, and departmental activities.

Initially, the schedule will closely mirror the manager’s onsite days, with increasing flexibility over time as the specialist becomes established in the role, subject to operational needs and meeting schedules.

The environment involves regular interaction with research assistants, regulatory staff, clinic coordinators, data coordinators, nurses, and administrative teams, with a strong emphasis on quality, compliance, and continuous improvement in oncology clinical trials.

Job Type & Location

This is a Contract to Hire position based out of Detroit, MI.

Pay and Benefits

The pay range for this position is $32.00 - $37.00/hr.

Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment.

Benefits are subject to change and may besubject to specific elections, plan, or program terms.

• If eligible, the benefitsavailable for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
• Workplace Type

This is a hybrid position in Detroit, MI.

Application Deadline

This position is anticipated to close on Jul 31, 2026.

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The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment.

An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates.

AI helps assess applicationsand qualifications, but final decisions are made by our hiring team.

By applying, youacknowledge and agree that your application may be reviewed using AI tools.

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