Clinical Trial Manager II

2 days ago

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Description

• Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable. • Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed. • Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters. • Review site specific Informed Consent Forms (ICFs) to address site specific changes and escalate to internal or external parties for approval, as needed. • Provide the Project Manager with metrics and updates on sites including but not limited to: study related site enrollment, site activations, protocol deviations, monitoring reports and follow-up letters status. • Assure proper maintenance of site required records for monitoring activities and required regulatory documents per CPC requirements. • Create and/or review study-specific monitoring visit reports and, follow-up letter templates, and project specific site materials including Monitoring Plans, ICF templates, Study Procedure Manual, source document and site newsletter. • Work with CRAs, RAs and new Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues. • Oversee Investigational Product (IP) release and once IP release has occurred, work with the RAs to collect all new or expiring Investigator regulatory documents. • Oversee and approve site activations and IP release. • Participate in project-related and other departmental/CPC meetings as required. • Oversee the selection of qualified sites and Investigators for participation in research protocols. • Work with sites to negotiate the study site budget. • Oversee tracking, request and work with the Finance department on processing study site payments. • Oversee project specific training of site staff. • Train new Clinical Trial Managers on reviewing and processing monitoring visit reports and follow-up letters, completing metrics and updates, tracking site specific documents, and creating project specific documents. • Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring and SEEV activities. • Work closely with other team members to ensure timely resolution of site issues. • Conduct drug tracking and disposition as required by project. • Overseeing remote monitoring. • Ensure Clinical Trial Management System (CTMS) remains up to date with all site trial activities including but not limited to site communications, document status, monitoring visits, protocol deviations. • Conduct site monitoring visits or co-monitoring visits, as needed.

Requirements

• Nursing or bachelor’s degree preferred. • A minimum of 3 years of experience in clinical research setting required. • Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. • Thorough understanding of the drug development process. • Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint). • Experience with electronic data capture systems. • Excellent interpersonal communication skills, organizational skills and a great attention to detail. • Ability to organize and instruct staff, while promoting group effort and achievement. • Ability to carry out multiple tasks simultaneously. • Ability to complete tasks in an accurate and timely manner. • Ability to manage conflicts and resolve problems effectively. • Ability to discern priorities with minimal direction to accomplish day-to-day tasks. • Willingness to travel up to 25% of the time.

Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) • Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) • 11 paid holidays • 15 - 25 vacation days based on years of service • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) • In-suite exercise and relaxation room • Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) • Flexible and remote work schedules