United Therapeutics Senior Clinical Research Associate (Northeast - CT, NY, MA) in United States
The Job Details are as follows:
What we do
About United Therapeutics
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our obsession with quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens — having a positive impact on patients, the environment and society — will sustain our success in the long term.
Through our wholly-owned subsidiary, Lung Biotechnology PBC, we are focused on addressing the acute national shortage of transplantable lungs and other organs with a variety of technologies that either delay the need for such organs or expand the supply. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company.
We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.
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, pediatric cancers and other orphan diseases.
How you’ll contribute
Work with Clinical Operations staff and monitor clinical research sites to facilitate study enrollment, confirm the accuracy of study data, supervise the conduct of clinical trials, build effective site relationships, and ensure sites are properly managed and compliant with applicable regulations. Perform all aspects of site management independently with minimal supervision.
Conduct site evaluation, site initiation, interim monitoring, and close-out visits; providing timely completion and turnaround of trip reports per guidelines.
Provide direction and training for other CRAs assigned to a study
Proactively drive project success, including working closely with CTLs to develop and implement enrollment strategies, monitoring and tracking tools
Provide skilled quality review of protocols and Informed Consent Forms (ICFs)
Train other CRAs on studies and UT processes through co-monitoring visits
Develop and deliver training at departmental meetings and investigator meetings, as required
Develop and implement study-specific monitoring tools
Serve as primary contact for site relationship management; cultivating productive relationships and understanding local challenges and opportunities
Provide site support for electronic data capture (EDC), reviewing for completeness and consistency and generating and resolving queries during monitoring visits
Meet regularly with PIs at sites regarding issues/concerns with the study
Advise and train site personnel on sponsor and regulatory requirements for study conduct, report preparation, and questions about EDC use.
Review on-site files and records, drug accountability, study supply inventory, case report forms, and source documents for completeness, accuracy, consistency, and compliance. Identify deficiencies and discrepancies, and provide remedial training and/or initiate corrective action as required
Collect, review and process regulatory documents and correspondence from clinical sites.
Track subject enrollment and participation at each trial site; developing and implementing recruitment plans to enhance enrollment as needed.
Maintain tracking tools for monitoring, regulatory document review, and follow up of issue resolution; including maintaining site information on Clinical Trial Management System (CTMS)
Attend and participate in project and team meetings
Represent the clinical monitoring function in cross-functional meetings and lead departmental initiatives
Gain knowledge of therapeutic area and clinical trial material (CTM) to be studied
Provide support of CTM activities at site and study level; including study drug forecasting, drug supply, and review and input on IVRS and drug accountability/ reconciliation
Collaborate with CTL and CRA manager in response to site audit findings
Perform other duties as assigned.
For this role you will need
BA/BS degree, preferably in life sciences
5+ years of experience with onsite monitoring as a Clinical Research Associate in the pharmaceutical/biotech/CRO industry
Current and/or previous experience as a home-based CRA
Experience with eTMF, CTMS and EDC
Working knowledge of regulatory and clinical practices (ICH, GCP)
Proficiency with MS Office suite
Strong organization skills and ability to communicate effectively with and present to cross-functional groups.
Ability to travel up to 75%. Ability to travel to international sites as needed.
8+ years of progressive experience in clinical research.
Detail-oriented and self-motivated with ability to prioritize work.
Ability to work independently and as part of a multi-functional team
Ability to handle high workloads, stressful situations and deadline
Life as a Unitherian
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.
We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level of job performance and provides state of the art facilities to flourish. This is what makes United Therapeutics a stimulating place to work.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
United Therapeutics currently has five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation, and achievement into success.