Associate Project Manager NCCT EducationRegulatory (Remote)

Full Time 1st shift

Pay Range

JOB 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: Bachelors 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. Masters degree in a relevant discipline preferred.

Our CommitmenttoYou:

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 teammates 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 andShort- 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.