Clinical Trial Coordinator
Reporting to the Head of Clinical Operations, the Clinical Trial Coordinator (CTC) will support the Head of Clinical Operations and other team members in day to day activities for the Clinical Operations department and clinical trials. The ideal candidate will have keen attention to detail and can prioritize and handle multiple tasks effectively in a rapidly growing department and company – and have the desire to learn about clinical trial operations.
- Play a key role in planning, management and conduct of internal team meetings, advisory boards, and other trial-specific meetings
- Support meeting logistics including: scheduling and set up, tracking attendance, preparing agendas, drafting meeting minutes, and collating materials before meetings
- Coordinate training for the department
- Work with the Clinical Operations team to review clinical documents (Protocols, Informed Consent Forms, study plans, and related documents) and prepare and maintain study materials as requested
- Support the study specific trial master file by filing and maintaining electronic trial master file (eTMF) for sponsor documents, and maintain audit ready clinical trials documentation
- Verify and track invoices and payments for selected vendors and sites in collaboration with finance and study team
- Develop an understanding of clinical trial research through exposure to clinical trial protocols, the drug development process, clinical operations meetings, company and department Standard Operating Procedures (SOPs), and International Conference on Harmonization (ICH) / Good Clinical Practices (GCP)
- The candidate must maintain a high standard of professionalism and confidentiality in this role, and must be able to problem solve, communicate effectively, and trouble-shoot creatively
- BS or BA required
- Solid grasp of MS PowerPoint, Word, and Excel
- Highly detail-oriented
- Good interpersonal skills and team player
- Strong oral and written communication skills
- Able to resolve conflicts in a diplomatic manner
- Demonstrated effective time management skills
- 1-2 years of experience in a pharmaceutical or biotechnology company
- Science background preferred
- Basic knowledge of ICH/GCP Guidelines and FDA regulations for conducting clinical trials
- Familiarity with applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs
- Experience with clinical study start-up process, global Phase I and II clinical trials preferred
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
If interested and qualified, please include Requisition # 2018-404 in the subject line when emailing resume to: firstname.lastname@example.org.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.