Location: Durham, NC
Company: United Therapeutics
goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation. We are the first publicly-traded biotech or medical company to take the form of a public benefit corporation (PBC).
Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel medical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization. Our company was founded
by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her.
We are founder-led, and relentless in our pursuit of " medicines for life" We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases. How you'll contribute Manage and support an inspection-ready Trial Master File (TMF) in compliance with United Therapeutics' SOPs and ICH/GCP guidelines by applying a solid working knowledge of clinical trial documents to resolve a variety of issues, while further developing professional expertise and begin to contribute
independently to the study team with regards to TMF activities.
Maintain the electronic TMF (e TMF) system including secure storage, retrieval, retention and destruction per United Therapeutic SOPs Begin to directly consult and support the Clinical Project Manager (CPM) throughout the course of the study, including providing metric reports as requested Follow up on open TMF queries and ensure full resolution Serve as a TMF contact for trial documentation to the project team and cross-functional departments Provide support in periodic audits of Clinical Research Organization (CROS) TMFs as well as internal UT audits Provide support to clinical teams during regulatory inspections in terms of record organization and retrieval Prepare TMF records for long-term, off-site archival in compliance with company SOPs and GCP procedures Support clinical trials data entry into the appropriate database (e.
g. CTMS), as needed Retrieve TMF records from long-term, off-site archival when requested Support in the development of departmental SOPs Support in the development of departmental manuals, tools and training processes Mentor and assist with the training of 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 Perform all other duties as required For this role you will need Minimum Requirements H.
S. Diploma or General Education Degree (GED) For Clinical Records Specialist II level: 6+ years of experience working in document management activities for clinical studies with prior experience in clinical research (clinical research associate, clinical research coordinator, start-up, etc. ) and increasingly independent interaction with various functional units with a H. S. Diploma or GED or 4+ years of experience working in document management activities for clinical studies with prior experience in clinical research (clinical research associate, clinical research coordinator, start-up, etc.
) and increasingly independent interaction with various functional units with an associate degree or 2+ years of experience working in document management activities for clinical studies with prior experience in clinical research (clinical research associate, clinical research coordinator, start-up, etc. ) and increasingly independent interaction with various functional units with a bachelor's degree For Senior Clinical Records Specialist level: 9+ years of experience working in document management activities for clinical studies, with prior experience in clinical research (Clinical Research Associate, Clinical Research Coordinator, Start-Up, etc.
) with significant and increasingly independent interaction with various functional units with a H. S. Diploma or GED or 7+ years of experience working in document management activities for clinical studies, with prior experience in clinical research (Clinical Research Associate, Clinical Research Coordinator, Start-Up, etc. ) with significant and increasingly independent interaction with various functional units with an associate degree or 5+ years of experience working in document management activities for clinical studies, with prior experience in clinical research (Clinical Research Associate, Clinical Research Coordinator, Start-Up, etc.
) with significant and increasingly independent interaction with various functional units with a bachelor's degree Strong 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 Commitment and ability to handle high workloads, demanding situations, and deadlines Ability to interact and communicate effectively, both written and orally, with colleagues and management, both within and outside Clinical Exceptional attention to detail and accuracy in work Ability to proactively identify potential issues and creatively formulate potential course(s) of action 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/Power Point Prior use of an e TMF, CTMS and/or EDC Phlex e TMF superuser experience or SME experience with another e TMF system Ability to co-author procedures (e.
g. SOPs, user manuals, TMF Management Plans) and review specific conventions and rules in relation to department's operational needs Preferred Qualifications Associate degree in an applicable discipline. Will consider commensurate experience and/or combination of education and experience, or Bachelor's degree preferably in biological sciences or an applicable discipline. Will consider commensurate experience and/or combination of education and experience Previous experience overseeing TMF audits and/or inspections Prior use of an offsite storage and retrieval system At United Therapeutics, you'll realize quickly that it is not an ordinary place to work!
When you join our company, you will learn, grow, contribute, have fun, and be challenged. all while making a difference in the lives of our patients. While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness.
Employees working in customer-facing roles must adhere and comply with customers' credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients. United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
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