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Open Position

Title: Clinical and TMF Operations Associate – TMF Lead

Location: Raleigh, NC

 

If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.

Role

Clinical and TMF Operations Associate:

The Clinical and TMF Operations Associate (CTOA) will manage regulatory site operations through the planning and execution of site activation, IRB submissions, interim monitoring visits, project communications, and project closeout. The CTOA will assess above processes for compliance with applicable regulatory authority, ICH/GCP, and TG Therapeutics’ SOP guidance. They will also contribute to and provide oversight of Trial Master File (TMF) maintenance activities for assigned sites and trials. They may also contribute to TMF scoped deliverables including TMF Plan development, TMF Index creation, TMF set-up, TMF filing, TMF tracking, TMF review, outsourced TMF oversight, and coordination of TMF Quality Control (QC) processes.            

Key Responsibilities

Perform Regulatory Start-up, Maintenance, and Closeout activities according to applicable regulations, SOPs, and guidelines

Serve as site/CRO regulatory contact and provide regulatory-related study updates to CRAs or trial project teams

Prepare site regulatory documents and packets

Perform essential document QC for completeness and accuracy

Monitor site level study activities to ensure regulatory compliance and provide recommendations as needed

Prepare and Submit central IRB documentation and provide support to central and local IRB/ECs during reviews

Contribute to the collection, interpretation, and dissemination of accurate IRB communication to support assigned studies and wider company, as required

Issue site communications such as site activation letters and site closeout notifications

Oversee study, country, and site level TMF creation and maintenance

Perform TMF reviews on site, country, or study level

Ensure accurate completion and maintenance of TMF and tracking tools with project specific information

Provide guidance and serve as a resource to co-workers

Participate in internal or external audits and regulatory authority inspections as needed

Performs other work-related duties as assigned

Professional Experience/Qualifications

Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; previous interaction with operational project teams and investigative sites preferred

Interacts with internal and external sites and vendors with high degree of professionalism and discretion

Adapts to a changing environment and handle multiple priorities

Excellent communication skills, oral and written

Self-motivation with the ability to work under pressure to meet deadlines

Works well independently as well as in a team environment

Computer proficiency (MS Office – Word, Excel, Power Point), aptitude for training, capable of operating standard office equipment and learning new systems

Education

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical, or laboratory technology)

High school diploma and at least 5 years relevant experience may be considered