Clinical Operations Assoc. Director, Clinical Trial Educator

What You'll Do

The Clinical Trial Educator (CTE) reports to and works with the Exec/Sr./Director of Clinical Operations to provide a high-touch service to clinical study investigators and site research teams. This is accomplished through ongoing engagement for Eidos clinical trials with a purpose of proactively increasing study and data quality and proactively identifying and mitigating operational risks. The CTE is a critical role in keeping the study “top of mind” with our sites, guiding sites through complex study procedures, and is one of the key Sponsor points-of-contact for the Principal Investigators and all clinical site research staff team members. The CTE will continually look for opportunities to optimize the execution of the study(ies) in such a way as to ensure robust protocol adherence, GCP compliance and high-quality data collection in a timely manner. The CTE

Responsibilities

• Maintains clinical knowledge of the therapeutic area landscape including current treatment strategies, current and pending competitors, and new therapeutic developments. 

• Establishes and maintains collaborative relationships with key therapeutic area experts, investigators, and institutions, serving as a key Eidos contact for investigative sites. 

• Collaborates with clinical development and operational teams, as well external service providers as appropriate to coordinate and optimize educational and research support for sites/investigators participating in BBIO's clinical trials, creating and contributing to study documents as needed.

• Provides ongoing evaluation of enrollment status by site to ensure they are meeting expected goals, as well as patient compliance and study completion. 

• Provides white glove experience and oversight of key study procedures procedure periods with identified needs, such as screening, working with sites to ensure understanding and guide through the process as needed. 

• Identifies and communicates key clinical and investigational study issues and insights from investigative sites to appropriate departments to help shape program level strategies, and assists study centers and CROs with “trouble-shooting” throughout the study, including site start-up activities, support during study maintenance, and supporting study endpoints through specifically training procedures. 
• As requested, participates in medical education for healthcare professionals through presentations and investigator interactions such as investigator meetings and other appropriate venues to enhance product and disease state knowledge. 

• May assist in CRA monitoring oversight as needed.  

Where You'll Work

This is a U.S.-based remote role that will require periodic visits to our San Francisco Office.

Who You Are

Historically the "Experience, Education, & Skills Requirement" section

(5-7 bullets max)

• BA/BS or MA/MS in biological or medical field required or relevant experience; advanced degree or clinical background preferred.   

• Minimum of 10 years of relevant clinical experience in the pharmaceutical, biotech and/or CRO industries, with at least 5 years of experience in a similar role. 

• Strong interpersonal skills and excellent relationship-building skills 

• In-depth Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required.  

• Clear scientific curiosity and interest in drug development   

• Strong verbal and written communication skills  
• Passion for helping patients.  
• Identifies and applies advanced practices, technical principles, theories and/or concepts, and contributes to the development of new principles and concepts; has a comprehensive understanding of current approaches in industry and ability to incorporate them into Eidos’ programs.
• Travel- 20%