Job: Senior Clinical Trial Assistant, Precision BioSciences, Durham, NC
Responsible for assisting the clinical operation team in ensuring the most effective and efficient conduct of clinical research studies by providing project support. This position maintains internal clinical files, supports team across multiple projects, assists with team meetings, and performs other related Clinical administrative tasks. The Senior Clinical Trial Assistant will be expected to function independently once familiar with the tasks of the job.
Essential Duties and Responsibilities:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
-Assist with the planning and management of internal/external Clinical meetings, such as creating agendas and taking minutes at meetings
-Assist in the development of tracking tools and reports for communicating study progress and key metrics to the management team
-Communicate to Clinical Operations team members on deliverables and ensure timelines are met
-Create internal study files; support maintenance for the duration of the study, assisting in the file review and reconciliation process in preparation for audits and archival. May conduct secondary review of Essential Regulatory Documents. May serve as project representative for TMF audits. May serve as in-house site contact for collection of non-essential regulatory documents, tracking and maintaining drug/study supplies, query resolution, administrative protocol and study related questions.
Assist with quality control checks for key study related materials e.g., Informed Consent Forms (ICFs), Investigator’s Brochures (IBs), and protocols
-Assist in the development of ICFs using project specific knowledge; perform in-house Case Report Form review
-Collaborate with team members on process improvements
-Assist with vendor management
-May train new employees assigned to project
-Complete other study-related tasks as required by Clinical Operations Team members
This is an office-based position located at the main headquarters in downtown Durham, NC
5 – 20% travel may be expected, with potential of up to 25% travel
This position is eligible for an annual target bonus, stock option grants, and a comprehensive and competitive benefits package
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
-BA/BS in the science/healthcare field, nursing degree, or equivalent combination of education, training and experience
-2+ years of experience in a clinical research setting preferred
-Research or health care related academic or work experience preferred
-Basic understanding and knowledge of ongoing protocol and disease related terminology, FDA regulations, GCP/ICH guidelines, drug development process for assigned study, as well as company SOPs and Work Instructions
-General knowledge of applicable clinical research processes including GCP and ICH guidelines
-Strong Computer skills including use of Microsoft Word, Excel and PowerPoint
-Strong written and verbal communication skills
-Effective time management and organizational skills
-Strong attention to detail and accuracy with demonstration of critical thinking and problem-solving skills
-Excellent customer service orientation
-Ability to work as a team member
Precision BioSciences is dedicated to improving life. Our mission is to cure genetic disease, overcome cancer, and feed the planet. We are achieving this with ARCUS, the first therapeutic-grade, naturally-derived genome editing system that uniquely combines the specificity and efficacy required to overcome life’s greatest genetic challenges. Learn more about the pioneers leading the next genetic revolution at: www.precisionbiosciences.com
Precision BioSciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.