Clinical Trial Specialist II

Job description

California, US residents click here. The job details are as follows: Who We Are 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; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). 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). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are 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: Develop, perform and track feasibility activities utilizing questionnaires, etc. to aid in investigator selection 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 and maintain master informed consent form template and revisions to the template throughout the study as necessary Develop, monitor and maintain the initial start-up package and essential regulatory document templates Manage the Central IRB/IEC vendor, as applicable to study; 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 May guide and mentor more junior-level staff ·Maintain state-of-the art-understanding of the field, through review of published materials, attendance at industry meetings, and completion of relevant coursework/seminars Minimum Requirements 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 Prior use of a clinical system technology (SSU, eTMF, CTMS, etc.) Working knowledge of ICH/GCP guidelines within a clinical environment and pertaining to the essential documents for the conduct of a clinical trial Outstanding organizational skills with the ability to multi-task and prioritize in a fast-pace environment Exceptional attention to detail and accuracy in work Effective written and verbal communication skills Creative and proactive problem-solving skills Demonstrated self-starter with a high level of commitment 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 Commitment and ability to handle high workloads, demanding situations, and deadlines Preferred Qualifications 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 Job Location 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. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. 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. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.