CRA Lead | Unique Career Opportunity | “First-in-Class” Gene Therapies | Rapidly Growing Biotech | NJ
This is a newly created position for an experienced site management professional to join an exciting, innovative, and rapidly expanding biotech company that focuses on developing novel first-in-class gene therapy treatments. You will report into a highly-regarded VP/Head of Clinical Operations and will handle responsibilities both in-house and at clinical sites. Given the smaller biotech culture, our client is seeking a candidate who is comfortable working in a fast-paced/hands-on environment and who wants to be part of something unique.
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 comradery and fast-paced/collaborative environment, while also having a diverse development pipeline and a proven leadership team.
Attractive Features about this Company & Opportunity:
- Cutting-Edge Gene Therapies: Gain tremendous experience working on game-changing gene therapies, and be part of a quickly-growing company that is primed for big things in the cell/gene therapy space.
- Great Career Opportunity: This is a very important and impactful new role where you will have the ability to truly impact the organization (unlike in Big Pharma).
- Excellent Time to Join: This is a great time to join this exciting high-growth biotech company, as they are starting to expand/build out their Clinical Operations team.
- Exciting 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).
- Ability to Make a Real Difference: As opposed to being a small fish in a big pond in Big Pharma, you will work in a lean, entrepreneurial and collaborative environment where you will have the autonomy and visibility to make a significant impact on the company’s success, as well as in the lives of patients suffering from devastating diseases.
- Visibility: You will report into a highly-regarded VP/Head of Clinical Operations (who we know personally) and work alongside of other senior leadership members.
- 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.
- 4+ years of relevant clinical operations site management experience at a pharmaceutical/biotech company or CRO.
- Clinical experience with rare/orphan disease products and/or gene therapy clinical trials, or a relevant complex therapeutic area is strongly preferred.
Brian Skurka, Partner
email@example.com - P 973-656-0220 x738
Cornerstone Search Group, LLC
6 Campus Drive
Parsippany, NJ 07054
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