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Open Position

Title: Clinical and TMF Operations Associate (CTOA)

Location: Raleigh, NC

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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

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

–           Serve as the disease area expert and providing support to cross functional team members, including onboarding and review of materials

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

Ability to adapt to a changing environment and handle multiple priorities

Detail and process oriented

Superb organizational and time management skills

Flexible and adaptable to a developing work environment; willingness to learn

Positive attitude and approach

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

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

Multi-tasking capability

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

Can travel domestically and internationally approximately 25% of the time (post-pandemic).

•           Willingness and ability to travel domestically and internationally, as required.

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)

Experience in scientific research and/or clinical trials