CRA/Sr.CRA (In-house) | Cutting-Edge Cell/Gene Therapies | Exciting & Quickly Growing Biotech | NJ/NYC
This is a newly created opportunity for an experienced Site Management professional to join an exciting, innovative, and fast-growing biotech company that focuses on developing novel first-in-class gene therapy treatments for rare diseases. You will report into a top-notch Head Clinical Operations and will handle responsibilities both in-house and at clinical sites through the management/monitoring of overall site conduct and establishing important relationships with key site personnel. Given the smaller biotech environment, our client is seeking a candidate who is comfortable working in a hands-on, highly-visible and autonomous type of role, and who is flexible and can positively collaborate cross-functionally across all levels within the organization.
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:
- New “Ground Floor” Opportunity: This is a very important and impactful new role where you will utilize your monitoring/site management experience, and have the ability to truly impact the organization (unlike in Big Pharma).
- Exciting 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 comradery, 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).
- Impact & Visibility: You will report into an excellent Head of Clinical Operations (who we know personally) and work directly with Senior Management and have the opportunity to make a meaningful impact from day one.
- Cutting-Edge Gene Therapies & Novel Technology: Leveraged by its unique technology and cutting-edge science, this company is on the forefront of a novel approach to cell/gene therapy treatments, opening up a vast domain for discovering innovative new medicines.
- 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.
- This person will be responsible for managing the Company’s clinical trials, and will be a key interface with the CROs and other vendors in support of the Company’s clinical trials, and clinical sites.
- 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.
- Lead/manage assigned sites through regular contact to ensure site compliance, adequate enrollment, and understanding of study requirements.
- 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.
- Prepare regulatory submissions, monitor patient safety and address protocol deviation, data quality issues, drug accountability and identify process improvements for assigned sites.
Education & Desired Experience:
- A bachelor’s degree in a nursing, scientific or life sciences discipline.
- 4+ years of relevant site management experience monitoring in-patient clinical trials at a pharmaceutical/biotech company or CRO.
- Established a track record of building key productive relationships with study investigators, site staff and personnel, etc.
- A successful candidate will have clinical experience with rare/orphan disease products and/or gene therapy clinical trials, or a relevant complex therapeutic area.
- Ability to travel to the sites, monitoring visits, etc.
Brian Skurka, Partner
firstname.lastname@example.org - 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