CRA/Sr. CRA | Remote Based – CA | Innovative Gene Therapies | Fast Growing Biotech
This is a newly created position and unique opportunity to join an exciting and well-funded clinical-stage biotech company focused on developing novel first-in-class gene therapy treatments for rare diseases. You will report into a highly-regarded VP/Head of Clinical Operations and will handle end-to-end site management responsibilities for the company’s breakthrough compounds. Given the smaller biotech culture, our client is seeking an experienced site management/monitoring professional with a strong science background who is comfortable working in a fast-paced/hands-on company environment and who wants to be part of something unique and special.
This is a very exciting time within the organization as they are growing across a number of departments, and this is a great opportunity to join an exciting company at the early stage in its growth and have the autonomy to truly impact the organization. This company has been attracting experienced and talented industry professionals and offers a small team camaraderie and fast-paced/collaborative environment, while also having a diverse development pipeline and a proven leadership team.
Attractive Features about this Opportunity & Company:
- Incredible Career Opportunity: This is a very important and impactful position where you will have a visible impact on the success of this company while gaining highly sought-after gene therapy experience working on potentially-transformative compounds.
- Exciting Time to Join: You will be joining at the perfect time (especially in terms of impact and career growth) as the company is growing quickly and progressing in development.
- Fast-Paced Biotech Culture: The company offers all the attractive features sought with an entrepreneurial development/clinical-stage Biotech (small team camaraderie, impact, nimble, quick decision-making, autonomy, minimal layers/bureaucracy) which fosters more collaboration, communication and swifter decision making (i.e. emphasis on progress and moving things forward).
- Cutting-Edge Science / Gene Therapies: Gain tremendous experience working on novel breakthrough gene therapies for a variety of rare diseases.
- High Impact: As opposed to being a small fish in a big pond in Big Pharma, you will work in a lean, collaborative, and hands-on environment alongside extremely and passionate team members.
Location: This person can be based anywhere in California.
- Responsible for the management/monitoring of overall site conduct and establishing important relationships with key site personnel.
- Perform site selection, study start-up, initiation, monitoring and close-out visits of investigational sites for the Company’s clinical trials.
- Manage the progress of assigned studies by tracking patient recruitment and enrollment, CRF completion and submission, source data verification, drug accountability, data collection, and data query generation and resolution.
- Develop collaborative relationships with investigative sites and personnel.
- Assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports for regulatory filings.
- Prepare regulatory submissions, monitor patient safety and address protocol deviation, data quality issues, drug accountability and identify process improvements for assigned sites.
- Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance.
- Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with management on protocol discrepancies, improving efficiency, data integrity, etc.
Education & Desired Experience:
- A Bachelor’s degree in a nursing, scientific or life sciences discipline is required.
- 5+ years of relevant clinical operations site management/monitoring experience at a pharmaceutical/biotech company or CRO.
- Clinical trial experience in gene/cell therapy, transplant or rare disease products is strongly preferred.
- The ideal candidate will have a strong passion and curiosity for science and gene therapy with a desire to bring needed cures from bench to bedside.
Brian Skurka | Partner
P: 973-656-0220 x738
CORNERSTONE SEARCH GROUP - Pharma & Biotech Executive Search
Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA
About Cornerstone Search Group: Recognized by Forbes as one of the Top Executive Search Firms in the USA (2017 & 2018), we are an industry-leading Pharma & Biotech Executive Search Firm that works with small biotech startups all the way through to large branded & generic pharmas. We are particularly known for our long history of success in helping small, lesser-known US and Internationally-based pharmas/biotechs compete for top talent at the Director, VP, and CxO (CEO, CMO, CSO, CCO] levels.
Keywords: Clinical Research Associate, Clinical Monitor, CRA, Clinical Site Manager, Clinical Site Management, Clinical Operations, Trial Management, Clinical Study Management, Clinical Trial Manager, rare diseases, gene cell therapy, orphan drugs