Clinical Research Associate / Sr. Clinical Research Associate

Parexel•Southport, NC

1d•Remote

About The Position

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Clinical Research Associate / Sr. Clinical Research Associate position working as a full-time employee of Parexel FSP on long-term assignment working remotely at one of our clients. The Clinical Research Associate (CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and Pfizer standards. The CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders. The CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close out of sites in a clinical trial. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Requirements

Knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Minimum 1 year relevant experience in clinical research site monitoring and management
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
Demonstrated ability to support sponsor regulatory interactions/inspections
Demonstrated knowledge of the processes around protocol design and feasibility assessment
Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
Ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial
Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Nice To Haves

Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience preferred

Responsibilities

Responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites
Ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and Pfizer standards
Accountable for site management and monitoring
Manage investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release)
Safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP)
Maintain investigator and site staff engagement and satisfaction
Enhance the company’s image with its external stakeholders
Responsible for the resolution of all protocol-related issues for assigned investigator sites
Work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close out of sites in a clinical trial