Department:
Status:
Benefits Eligible:
Hours Per Week:
Schedule Details/Additional Information:
Full Time, 1st shift
Pay Range
$28.55 - $42.85JOB SUMMARY
The Advocate Health National Center for Clinical Trials (NCCT) serves as an innovative platform to accelerate the conduct of clinical trials and the translation of scientific discoveries into meaningful improvements in patient care. NCCT provides centralized services for patient recruitment and enrollment, trial administration and follow-up, and the generation of real-world data and evidence.
The Project Management Associate (PM Associate) will support NCCT Education and Regulatory initiatives and will work closely with project managers and leadership. This role focuses on coordination, documentation and administrative support across multiple initiatives, including education and regulatory clinical research projects, clinical research personnel records management and regulatory systems implementation and maintenance.
ESSENTIAL FUNCTIONS
Centralized Clinical Research Personnel Records Management
- Manage and maintain all investigator and research staff personnel records, serving as the central point of coordination for regulatory-required documentation.
- Collect, review and track investigator and staff CVs, professional licenses and required trainings (e.g., CITI, GCP, Florence training).
- Provide clear instructions and guidance to investigators and study personnel on completing required regulatory and training requirements.
- Monitor expiration dates for training and credentials and proactively follow up to ensure continued compliance.
- Perform regulator QA reviews to ensure completeness, accuracy and audit readiness.
Regulatory Systems Implementation and maintenance
- File and maintain clinical research personnel credentials and training documentation within Florence eBinders in accordance with required structure, nomenclature and compliance standards.
- Manage Florence user accounts and role based access, including onboarding, modification and removal of access for investigators, research staff and external monitors.
- Coordinate external monitor access and training including:
- Verification of required training completion prior to system access
- Provisioning and troubleshooting access permissions
- Support ongoing compliance through auditing, reminders and escalations when needed.
- Attend Florence product release meetings. Assist with conducting UAT and validation.
- Provide implementation support for e-regulatory software solutions under the guidance of Education/Regulatory Project Manager II.
- Support development and maintenance of SOPs and job aids related to e-regulatory systems, including standardized folder structures, document naming conventions, and role-based access.
- Assist with tracking user training sessions for regulatory systems.
- Process software access requests for internal staff and external monitors according to established procedures.
- Run standard reports to support monitoring of system utilization and training completion.
ADDITIONAL RESPONSIBILITIES
- Maintain organized project documentation and status trackers.
- Assist with preparation of summaries, dashboards and presentations for leadership review.
- Participate in continuous improvement efforts related to NCCT regulatory operations.
- Perform other duties as assigned in support of Education and Regulatory initiatives.
EDUCATION/EXPERIENCE: Bachelor's degree in Education, Public Health, Basic Science, or a relevant clinical discipline with two years research experience. Preferred candidates will have experience working with electronic file systems (e.g., medical records, clinical trial management systems, eBinders) and demonstrated ability in reporting and spreadsheet management. Master's degree in a relevant discipline preferred.
Our Commitment to You:
Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:
Compensation
Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance
Benefits and more
Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program
Note: Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, per diem, temporary, etc.); please ask a Recruiter for more information during an interview.
About Advocate Health
Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.
