Open Position
Title: Clinical and TMF Operations Associate
Location: Remote
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
Organizational Overview
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit www.tgtherapeutics.com.
Role
The Clinical and TMF Operations Associate (CTOA) reports to the Sr. Manager, Clinical and TMF Operations. The CTOA will be responsible for assigned regulatory site operations through the planning and execution of site activation, IRB submissions, interim monitoring visits, project communications, and project closeout. They will also be responsible for submission and provide oversight of Trial Master File (TMF) maintenance activities for assigned sites as well as reviewing and approving Site Study Start-Up and TMF Reconciliation packages.
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
––May prepare and submit central IRB documentation for respective program and provide support to central and local IRB/ECs during reviews
––Contribute to the collection, interpretation, and dissemination of accurate IRB communication to study teams, as required
––Issue site communications such as site activation letters and site closeout notifications
––Oversee country and site level TMF creation and maintenance
––Perform TMF reviews on site or country level
––Ensure accurate completion and maintenance of TMF and tracking tools with project specific information
––Participate in internal or external audits and regulatory authority inspections as needed
––Create and maintain study start-up regulatory packets
––Routinely review TMF trends to ensure site level items are addressed
––Perform 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
––Familiarity of clinical research process and procedures
––Excellent organization, time management, and critical thinking skills
––Interact with internal and external customers and vendors with high degree of professionalism and discretion
––Efficient in a small team environment
––Computer proficiency, aptitude for training, capable of learning new systems
––Strong communication skills both oral and written, specifically with medical/clinical material
––Willing to work in a fast-paced environment where individual initiative, strong sense of compliance and ethics, and accountability to the team are required.
Education
• Bachelor’s degree (BS/BA) required (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (eg nursing certification, medical, or laboratory technology)
TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.