Research Program Coordinator II -Maternal Health Research Center of Excellence

mcw

Milwaukee (WI)

Sur place

USD 65 000 - 95 000

Plein temps

Il y a 4 jours
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Avantages offerts par ce poste

Health insurance
Vision insurance
Dental insurance
Flexible spending account (FSA)
403(b) retirement package
Paid vacation and holidays
Tuition reimbursement

Résumé du poste

MCW in Milwaukee seeks an experienced Clinical Trials Operations Coordinator to oversee day-to-day activities for a portfolio of maternal-fetal medicine trials. You will coordinate across sites, manage documentation, and keep milestones on track to meet sponsor requirements.

Responsibilities include leading meetings, tracking enrollments and progress, and ensuring timely submissions while maintaining data integrity and regulatory compliance.

Qualifications

  • Bachelor's degree required or equivalent
  • Minimum 3 years of experience coordinating multisite clinical research
  • Preferred: Bachelor's or Master's degree
  • Experience with NIH-funded projects and regulatory documentation is a plus
  • Familiarity with IRB processes is preferred

Responsabilités

  • Coordinate operational activities across multiple clinical studies and participating sites; maintain master study calendars, milestone trackers, and logs.
  • Organize investigator meetings, steering committees, site coordinator meetings, and working groups; prepare agendas and circulate minutes.
  • Proactively follow up with study teams on approvals, data requests, training, and deadlines; escalate delays to leadership.
  • Coordinate site onboarding, activation checklists, and start-up materials with regulatory and grants staff.
  • Disseminate protocol updates and standardized forms across sites; maintain study resources and documentation.
  • Plan site visits and training sessions; track attendance and completion records.
  • Maintain organized study databases and dashboards with access controls.
  • Compile site-level progress updates; report enrollment, retention, and milestone achievement.
  • Prepare operational status summaries for PIs and study leadership.
  • Assist with sponsor reports, annual progress reports, and manuscripts; track submission timelines.
  • Act as liaison among investigators, staff, institutions, partners, and support offices.

Connaissances

Organization
Project management
Communication
Multisite coordination
IRB familiarity

Formation

Bachelor's degree
Master's degree

Outils

Microsoft Office
Excel
Outlook
Teams
SharePoint
REDCap
CTMS

Description du poste

Summary

Work closely with the Principal Investigator(s), research leadership, clinical research coordinators, and collaborators to coordinate the day-to-day operational and administrative activities of a portfolio of maternal-fetal medicine clinical trials and related research studies. Serve as a central point of coordination for multisite projects, ensuring effective communication, organized study documentation, timely completion of deliverables, and consistent follow-through across participating institutions. Support study start-up, implementation, reporting, and closeout while facilitating achievement of research milestones and sponsor requirements.

Primary Responsibilities
  • Coordinate operational activities across multiple clinical studies and participating sites; maintain master study calendars, milestone trackers, site contact lists, and deliverable logs.
  • Organize investigator, steering committee, site coordinator, and working-group meetings across institutions; prepare agendas, distribute materials, document decisions, and circulate minutes and action items.
  • Proactively follow up with study teams and external collaborators on outstanding materials, approvals, data requests, training, action items, and deadlines; elevate delays or risks to study leadership.
  • Coordinate site onboarding and activation checklists, including collection and tracking of required documents, training records, delegation logs, agreements, and other start-up materials in collaboration with regulatory and grants staff.
  • Facilitate consistent dissemination of protocol updates, manuals of procedures, standardized forms, recruitment materials, and other approved study resources across sites.
  • Organize site visits, investigator meetings, training sessions, and virtual events; coordinate logistics and maintain attendance and completion records.
  • Maintain organized shared files, document version controls, study databases and operational dashboards with appropriate access permissions.
  • Compile site-level progress updates, including enrollment, retention, visit completion, data-query status, and milestone achievement, using information supplied by authorized study personnel.
  • Prepare regular operational status summaries for PIs and study leadership, highlighting overdue tasks, upcoming deadlines, dependencies, and items requiring decisions.
  • Assist with sponsor reports, annual progress reports, presentations, manuscripts, and other project deliverables by coordinating inputs and tracking submission timelines.
  • Act as a professional liaison among investigators, research staff, collaborating institutions, community partners, and institutional support offices.
  • Weekly study dashboard: provides the PI with one overview of recruitment, milestones, deadlines, and outstanding issues across trial.
  • Assist leadership and grants administration with budget tracking, invoices, subcontract milestones, purchasing, reimbursements, and site payment documentation.
  • Coordinate staff onboarding, interview logistics, scheduling, and training documentation as requested.
  • Help develop and update study communications, educational materials, standard operating procedures, websites, and forms; perform other related duties as assigned.
Knowledge - Skills - Abilities

Strong organizational and project-management skills; ability to coordinate multiple concurrent studies, anticipate deadlines, follow through independently, and communicate clearly across sites. Proficiency with Microsoft Office (especially Excel, Outlook, Teams, and SharePoint) and familiarity with tracking tools and data collection tools such as REDCap. Discretion with confidential information; collaborative, culturally responsive communication; attention to detail and problem-solving. Familiarity with human-subjects research, Good Clinical Practice, and IRB processes is preferred.

Qualifications
  • Appropriate experience may be substituted for education on an equivalent basis.
  • Minimum Required Education: Bachelor's degree
  • Minimum Required Experience: 3 years
  • Preferred Education: Bachelor's or Masters
  • Preferred Experience: Experience coordinating multisite clinical research, NIH-funded projects, academic medical center workflows, REDCap/CTMS, regulatory documentation, and meeting facilitation
Physical Requirements

Work requires occasionally lifting moderate weight materials, standing, or walking continuously.

Work Environment

Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.

Sensory Acuity

Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.

Why MCW?
  • Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
  • 403B Retirement Package
  • Competitive Vacation and Paid Holidays offered
  • Tuition Reimbursemen
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