Open Position
Title: Autoimmune Site Liaison
Location: Raleigh/Durham, North Carolina
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 approval from the United States Food and Drug Administration (FDA) 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, in adults. TG has also received approval for BRIUMVI by the European Commission (EC) for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features. TG Therapeutics has offices located in New York City, New Jersey, and Raleigh, NC. For more information, visit www.tgtherapeutics.com.
Role
The Autoimmune Site Liaison (ASL) is an entry level position supporting Clinical Operations. The ASL position will report to the Director of Study Operations. Each ASL will cover specific clinical trial sites, supporting TG clinical trial activity from study start-up through close out.
Key Responsibilities
Responsibilities include, but are not limited to:
––Assists in the overall support of clinical trials including various projects with specific emphasis on clinical trial site preparation and patient enrollment tasks
––Coordinates Study Start Up Activities including, but not limited to:
———– Works cross-functionally with Clinical Operations in support of timely site start-up
———– Manages execution of Confidential Disclosure Agreements (CDAs) and Master Clinical Trial Agreements (CTAs)
———– Develops study-specific budget, statement of work, or other related contractual documents
———– Negotiates and manages site budgets and contracts using the established negotiation and escalation plan
———– Accurately forecasts contract execution timelines and raises issues to Study Lead as appropriate
———– Maintains study-site listing, collects study site contact information, and inputs information into appropriate documents and systems
———– Vendor access management
———– Assist with preparation, handling, and distribution of applicable clinical trial supplies to study-sites
———– Submits relevant documents to the Trial Master File
———– Participates in stakeholder SME and cross-functional meetings and maintains a positive working relationship with internal team and external sites
Additional Responsibilities
–– Coordinates Study Conduct Activities including, but not limited to:
———– Identifies elements that trigger an out-of-scope activity and work with the study team to prepare updated study-specific contractual documents
———– Ensure clinical trial sites receive necessary clinical trial supplies
———– Tracks study metrics including site activation and enrollment trends/analysis and provide weekly updates to the clinical team
———– Assists team members in identifying actual and potential site problems/issues and in the development of action plans to ensure resolution, including escalation of appropriate issues in a timely manner
———– Develops and maintains various databases to support the clinical team
———– Assists in the coordination of meetings with various team members and site personnel
———– Submits relevant documents to the Trial Master File
–– Ad Hoc projects, as assigned
Professional Experience/Qualifications
––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
––Highly proficient in MS Word, Excel, and PowerPoint
––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 with a degree in the sciences preferred
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.