The Sr. Clinical Research Associate (CRA) will be involved in all aspects of clinical trial development and management. The Sr. CRA will work directly with sites, physicians, CROs, and other contracted groups to manage all daily and developmental aspects of current and future clinical trials.
- Assist in the coordination of clinical operations required to initiate, execute, and complete clinical trials to drive on time delivery of clinical trial milestones.
- Create and organize relevant clinical documents, including study protocols, data collection documents, regulatory compliance documents, monitoring plans, training documents, standard operating procedures.
- Maintain communication between the sponsor and all existing and future sites, PIs, and contractors.
- Provides support to the clinical department to assist with execution and maintenance of clinical studies.
- Maintains, updates, and may establish various databases for clinical tracking.
- Assists with maintaining metrics such as patient status and timelines for various activities pertaining to the clinical development program.
- Maintains clinical operations files.
- Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites.
- Prepares materials and attends investigator meetings, vendors meetings, ad hoc committee meetings as required.
- Provide day to day operational support for all ongoing protocols as requests from PMs arise.
- Assist with Raleigh office management to ensure clinical team is functioning at maximum capacity.
- Gather data and formatting for documents, managing timelines for submission deadlines such as compiling comments from internal reviews and formatting.
- Create, modify and format slides for the clinical team to assist with KOL/vendor meetings/ad hoc committee meetings.
- Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards.
Undergraduate degree in science discipline required
3+ years of clinical trial experience
- Strong understanding of clinical drug development and GCP and familiarity with regulatory requirements for conduct of clinical trials.
- Strong attention to detail.
- Excellent written and oral communication skills.
- Able to effectively use information technology with a proficiency in MS Outlook, Word, Excel and PowerPoint.
- Exceptional planning and organizational skills.
- Ability to multi-task and use good judgment when making decisions.
- This role requires 30-40% travel, primarily inside the US, with some international travel possible.
ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.