Clinical Trial Associate; One

Position: Clinical Trial Associate (One-Year Contract)
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* Job Description:

**** Company Overview
** Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines.

To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
** Position Summary
** Working closely with the Sr. Clinical Trial Manager and Clinical Operations Team, the Clinical Trial Associate (CTA) contract position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies in accordance with applicable regulations, Good Clinical Practice (GCP), and CRISPR Therapeutics standard operating procedures (SOPs). The CTA will support the Sr.

Director of Clinical Operations and Clinical Trial Managers (CTM) in day-to-day activities for managing clinical trial conduct. The ideal candidate will have keen attention to detail and has the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment.

This incredible opportunity will put the right candidate at the forefront of medicine, working on ground breaking trials with tremendous potential to impact patient's lives.  You will join a team of incredibly dedicated professionals whose talent is matched by their commitment and passion for the work we are doing.  A team that remains focused on what's important for the patient and also has an incredible track record of growth and development among them.  

If you are looking to learn, work hard, and make a difference, we would like to speak with you.
** Responsibilities
* ** Help maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
* Coordinate study documents and training tools for coordination with clinical sites
* Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
* Coordinate study meetings, materials and agendas; record and disseminate decisions and actions
* Responsible for internal meeting agendas/minutes as applicable
* Responsible for updating, maintaining and quality control of the eTMF and other document repositories
* Responsible for study laboratory sample tracking and vendor management support
* Track new vendors and purchase orders in financial system
* Coordinate version control of clinical documents, prioritize multiple tasks and/or projects
* Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages
* Support Clinical Operations team with specific projects
* Effectively communicate with study team members and work closely to address challenges
** Minimum Qualifications
*** BS/BA degree or equivalent and at least 1-3+ years experience in a Sponsor company
* Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures
* Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations
* Experience with eTMF; ability to directly apply essential document knowledge to file documents
* Effective communication, organizational and interpersonal/team skills
* Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project and SharePoint preferred.
* Established ability to prioritize and manage multiple tasks…