Position Title: Clinical Project Manager, Regulatory Affairs
Organization: American Thrombosis and Hemostasis Network (ATHN) Position
Type: Full time
Supervisor: Director of Research Programs
Location: Home office
Executes ATHN-sponsored network-based projects according to project timeline and funding. As the primary liaison with investigators, site staff and sponsor representatives, directs study launch, implementation and close-out phases. Tracks and critically assesses project implementation at sites; collates network-level information for committee oversight.
Working with ATHN Technical Team and Support, supports sites and study staff to ensure active site participation and smooth implementation of
Assist in setting up ATHN’s clinical trial research program
Advise ATHN’s leadership on the regulatory requirements for datasets, observational studies and clinical trials.
Working with each project Steering Committee and relevant ATHN team members, identifies and recruits qualified sites for each project; and ensures compliance with participating site eligibility requirements, based on established requirements for IRB approvals, patient authorizations/consents, protocols, ATHN Affiliate Agreements, Business Associate and Data Use Agreements, ATHN policies and other legal and regulatory
Participates in meeting, planning and administration to support study committees. Staffs Steering Committees and other assigned Committees, manages webinar and meetings; creates and distributes meeting invitations, agendas, minutes, supporting documents, reports, etc. May chair or present (in-person or via webinar).
Plans and distributes timely and informative study communications, including study documentation, investigator/site training (e.g., webinars), targeted print materials (i.e., newsletters, study brochures, operations memos, email).
Responsible for projects utilizing central IRB: communication with site staff, submission, maintenance, and close-out.
Maintain project files (electronically, using shared network resources) including protocols, case report forms, supplemental materials, consent documents, investigator meeting minutes, IRB approvals, site/study personnel credentials and correspondence. Includes maintenance of clinicaltrials.gov and other databases, as appropriate. Maintains all project-related tracking and reporting.
Produces and/or assists with creating and ensuring accurate and timely study reports for committees, investigators, sponsors, and funders. Review data listings and data reports provided by project statistician and/or Technical Team. Participates in data management activities to ensure submission of complete and accurate data. Ensures Safety reports are being submitted and reviewed per contract and relevant regulation.
Communicates with ATHN staff and external personnel to plan and achieve milestones and provide deliverables based on contracts and timelines.
Works with Director of Finance to ensure HTC Payments are planned and delivered, according to executed contracts. Assists with project invoices to funders as requested, based on agreed upon terms and milestones.
Builds and strengthens relationships with the growing number of ATHN-affiliated sites, investigators and sponsors.
Identifies and problem solves barriers to implementation (e.g., staff training, material templates, organizational workflow)
Work with study publications committee to target and address peer review publication opportunities.
Ensures that ATHN Affiliates are fully informed regarding research projects.
Travel: Limited – 2 to 4 times per year for project team meetings and scientific conferences
BA or BS. Master’s in Public Health, Research related degree or Project management preferred.
A minimum of 10 years’ experience in a research-related field (e.g., study coordination, regulatory, or other clinical research initiatives) required;
A minimum of 3 years’ experience in regulatory for observational studies and/or clinical trials
Experience in bleeding disorders, a plus
Ability to work independently to meet team goals and to plan workload based on established priorities and directives
Must be able to work in collaborative, multidisciplinary, distributed environment and be highly self- motivated and dedicated. Team player a must.
Excellent project management and organizational skills
Excellent interpersonal skills, with strong oral and written communication skills
Proficient, with advanced skills in Microsoft Word, Excel and PowerPoint
Additional Salary Information: Amount is dependent on experience and education of selected applicant.
Internal Number: CPMR
About American Thrombosis and Hemostasis Network
The American Thrombosis and Hemostasis Network (ATHN) is a non-profit, 501(c)3 corporation founded in July 2006. ATHN’s vision is to advance and improve the care of individuals affected by bleeding and thrombotic disorders. ATHN provides stewardship of a secure national database infrastructure, adherent to all privacy guidelines which will be used to support clinical care and outcomes analysis, research, advocacy and public health reporting in the hemostasis and thrombosis community. ATHN strives to be the most convenient, accessible and sought after network and database to facilitate research in the bleeding disorders and thrombotic disorders. ATHN currently supports a network of over 140 affiliated sites conducting research studies, surveillance, and Quality Improvement (QI)initiatives.