About this opportunity
United Therapeutics Corporation lists this Clinical Trial Specialist II opportunity in charlotte, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
You will partner closely with global clinical study teams to perform efficient study start-up activities serving as the lead contact with investigator sites during assigned study-start-up. Work independently to provide strategy for the efficient collection and review of study start-up documents, including essential regulatory documents from clinical sites, to facilitate effective study start-up according to established practices under general supervision.
~ Maintain proficiency with all responsibilities assigned to the Clinical Trials Specialist I role with a high degree of proficiency, accuracy, and autonomy
~ Coordinate and guide all start up activities prior to initial critical document package completion, including but not limited to:
~ Support investigators and site staff in fulfilling obligations regarding local submissions according to local regulatory and Institution Review Board (IRB) / Independent Ethics Committee (IEC) requirements
~ Assist with the customization, review, configuration of country / site specific Informed Consent Forms (ICF) as required
~ Provide initial essential document collection, review, and approval ensuring that sponsor and investigator obligations are being met and follow applicable local regulatory requirements and ICH/GCP guidelines
~ Create study-specific manuals, tools and templates (investigator site file, subject materials, etc.)
~ Develop, monitor and maintain the initial start-up package and essential regulatory document templates
~ Maintain Central IRB/IEC study-level documents and approvals throughout the duration of the clinical study, as applicable
~ Ensure continued inspection preparedness by maintaining contemporaneous study and site milestones in appropriate systems and data sources
~ Maintain inspection readiness by ensuring contemporaneous study, country, and site document filing, as applicable, in Trial Master File
~ Identify and organize translation needs per study and site; Collaborate with the translation vendor and study/site teams to organize and procure necessary translation documents, as applicable
~ Regularly analyze and monitor adherence to overall study and site start-up timelines; Provide alternative dates and strategy recommendations to clinical study teams and study leadership when necessary
~ Monitor and maintain accurate site demographic and status information, as applicable, utilizing applicable systems, tracking tools, etc
~ Ensure timely and accurate study-related communication to internal and external study teams (including CRO and site personnel as appropriate)
~ Assist in the development of SOPs and management of departmental manuals, tools, and training processes
~ Serve as a liaison with the CPM, CTC, and other members of the clinical study team
~ Assist in preparation and distribution of clinical trial correspondence, newsletters, etc
~ Maintain state-of-the art-understanding of the field, through review of published materials, attendance at industry meetings, and completion of relevant coursework/seminars
Bachelor’s Degree
~3+ years of experience working in start-up activities for clinical studies or equivalent experience in clinical research (Clinical Research Associate, Clinical Research Coordinator, Clinical Trial Management, etc.) with significant and increasingly independent interaction with the various functional units of the corporation
~ Working knowledge of ICH/GCP guidelines within a clinical environment and pertaining to the essential documents for the conduct of a clinical trial
~ Creative and proactive problem-solving skills
~ Strong customer service orientation
~ Competent end user of Microsoft Office software suite including Word/Excel/Outlook/PowerPoint
~ Ability to interact and communicate effectively, both written and orally, with colleagues and management, both within and outside Clinical, including upper management, vendor personnel, and clinical investigators and site personnel
~ 5+ years of experience working in start-up activities for clinical studies or equivalent experience in clinical research (Clinical Research Associate, Clinical Research Coordinator, Clinical Trial Management, etc.) with significant and increasingly independent interaction with the various functional units of the corporation
This position will be located in the RTP, NC office of United Therapeutics. Currently this job is a onsite role requiring five days per week in the office.
We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.