Regional Lead CRA | Exciting Ground-Floor Opportunity | Remote-based | NJ/NYC: RETAINED SEARCH

Cornerstone Search Group
Published
December 6, 2018
Location
Greater New York City Area, United States
Category
Job Code
bcsBH2687csg
Contact Email
bskurka@cornerstonesg.com

Description

Regional Lead CRA | Exciting Ground-Floor Opportunity | Well Funded NJ Biotech: RETAINED SEARCH

Summary:  Cornerstone Search Group has been retained by an exciting pre-IPO biotech company whose lead clinical candidate is a first-in-class, treatment that will revolutionize epileptic treatment. In this newly-created role, you will report into the VP Clinical Operations and work right alongside the founder/CEO and Chief Medical Officer. Given the smaller biotech environment, our client is seeking an experienced clinical site monitoring operations professional who is hands-on, flexible, forward-thinking, and can positively collaborate cross-functionally across all levels within the organization.  This company has been attracting experienced and talented industry professionals and offers the “best of both worlds,” (i.e. small team comradery and a nimble, entrepreneurial environment where smart decisions are made quickly minus the red tape/bureaucracy, while also having the financial backing of some top-tier healthcare investors.  As opposed to being a small fish in a big pond at a large organization, you will be a visible part of this company’s strategy, direction, and success.

Company:  This pre-IPO biotech has a well-proven leadership team with proven success leading pre-IPO companies and prior success in this therapeutic area.

Location:  This is a remote-based position (w/occasional team meetings in Summit, NJ).

Attractive Features about this Position and Company:

  • Visible and Impactful New Position: This is a very important and impactful newly-created role where you will utilize your monitoring/site management experience.  This is a position where you will have the ability to truly impact the organization (unlike in Big Pharma).
  • Exciting Company: Work for a unique biotechnology company which is focusing on innovative therapies.
  • Great Time to Join: This is a perfect time to join this company while they are at the ground-floor and an exciting inflection point as they are advancing further into development.
  • CEO’s Track Record of Success: The CEO (who we know personally) has extensive leadership experience in the biotech industry and he is very personable and genuine.

Responsibilities:

  • Manage site selection, 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.
  • Oversee and conduct monitoring activities, develop collaborative relationships with investigative sites and personnel.
  • Lead/manage assigned sites through regular contact to ensure site compliance, adequate enrollment, and understanding of study requirements.
  • Assures that clinical sites are being managed properly and ensures action plans are put in place as needed to ensure compliance.
  • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
  • Accountable for the implementation and management of overall project and quality systems required for GCP and GMP compliance during clinical product development.
  • Ensures regulatory inspection readiness at clinical sites.

Desired Background & Experience:

  • A bachelor’s degree in life sciences or related field.
  • 5+ years of relevant and progressive experience in on-site monitoring of clinical trials working at a pharmaceutical and/or biotech company, or a CRO.
  • Experience with quality procedures and vendor audits preferred.
  • Proven ability to work effectively in a fast-paced entrepreneurial environment, to be self-motivated, and to communicate effectively with senior management.
  • Willingness and flexibility to travel up to 70% (Investigator meetings, site visits, etc.).

Cornerstone’s Privacy Policy:

Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted/shared with us as confidential information.  Any information provided/shared with us will not be shared with any parties outside of Cornerstone Search Group without your prior permission.

Contact:

Brian Skurka | Partner

bskurka@cornerstonesg.com – P 973-656-0220 x738

LinkedIn: https://www.linkedin.com/in/brianskurka1

CORNERSTONE SEARCH GROUP - Life Sciences Executive Search
6 Campus Drive | Parsippany, NJ 07054 USA

www.cornerstonesg.com

USA: 973.656.0220

CH: 41 61 508 7010

Apply
Drop files here browse files ...
PDF and .doc resume uploads are preferred. docx files are not supported.