Clinical Trial Management Associate

Role Summary

The Clinical Trial Management Associate (CTMA) works as part of the Study Management Team to contribute towards the successful management and execution of clinical trials.

Responsibilities

• Conducts study tracking (e.g., CTMS, start-up, milestone, close-out); generates, reviews and distributes management reports from internal tracking systems at requested intervals
• Collaborates with the Clinical Trial Manager and/or the Clinical Project Lead on the development of certain study-specific plans and/or processes
• Presents at team meetings as needed (i.e., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training, etc.)
• Collects and reviews essential documents from Investigational sites
• Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents
• Participates in study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation
• Contributes to the development of the Monitoring Plan and assists with ensuring appropriate quality and timely monitoring of clinical sites
• Assists in development of study materials, case report forms (CRFs), informed consent documents for clinical studies
• Works with internal and external team members (i.e. Clinical Supplies, Toxicology PK, Regulatory Affairs, Clinical Data Management and CRO/Vendors) to deliver high quality trial execution
• Prepares investigational site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)
• Acts as primary contact for study contractors (e.g., contract CTMs, field CRAs)
• Keeps the Clinical Project Lead (CPL) informed of the progress of projects
• Develops and maintains good working relationships with Investigators and study staff
• Assists in the organization and preparation of and participates in Investigator Meetings (as applicable)
• Performs document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, invoices, and other study documentation
• Executes meeting logistics (e.g., schedule meetings, distribute meeting agendas and minutes), as needed
• Ensures timely study entry and updates to ClinicalTrials.gov
• Assists with design and preparation of study related materials for the training of internal and external staff
• Participates in co-monitoring activities and oversight of CRO or contract CRAs for pre-study, initiation, routine monitoring, and closeout visits
• Assists with the tracking and management of study specific budgets
• Participates in development of departmental processes, SOPs, and initiatives
• Assists with facilitating resolution of data queries and requests from Clinical Data Management
• Travel is variable and estimated at 20%

Qualifications

• Bachelor‚Äôs Degree preferred
• Minimum of two (2) years in clinical research or healthcare related industry, or equivalent combination of education and experience; site monitoring experience a plus
• Experience in scientific discipline and multiple therapeutic areas preferred
• Experience/training in GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security, HIPAA, Drug Development and Approval Process
• Proficiency in MS Office including Word, Excel, and PowerPoint