RETAINED SEARCH: Sr. CRA / Site Relationship Manager (RN/ASN/BSN/NP/PA) | Exciting Biotech | RTP, NC

Cornerstone Search Group Published: July 24, 2017
Category
Job Code
lrBH2618csg
Contact Email
lcrodriguez@cornerstonesg.com

Description

RETAINED SEARCH: Sr. CRA / Site Relationship Manager (RN/ASN/BSN/NP/PA) | Exciting Biotech | RTP, NC

Summary:  Our client is an exciting biotech company whose lead candidate is a first-in-class, “Fast Tracked”, immunotherapy treatment that is in Phase III development for a life-threatening indication in the critical care setting. This is a unique Sr. CRA opportunity in that its focus is on “Site Relationship Management”, and as our client is focused on critical care indications, they are ideally seeking individuals with RN, ASN/BSN/MSN, Nurse Practitioner, or Physician Assistant credentials. While our client utilizes their CRO’s Field Monitoring CRAs for standard monitoring activities, in this role you will serve as the “face of the company” to the investigational sites, working closely with Principal Investigators, Study Coordinators, and other Site Personnel to ensure that all processes are in place and functioning to eliminate barriers to enrollment and enhance screening activities. 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 can positively collaborate cross-functionally across all levels within the organization including the CMO and CEO.

Location: Research Triangle Park metro area, North Carolina

Company:  This well-funded biotech has an experienced and proven leadership team with a successful track record of leading similar types of organizations and who have prior success in this important therapeutic area.

Attractive features about this position and company:

  • Visibility & Impact: A challenging, highly-visible role where you will work alongside the CMO, Clinical Op Leadership, and other senior-level executives.
  • Exciting Company: This biotech is focused on developing novel immunotherapy settings for critical care “life threatening” therapies. Their lead candidate has received both “Fast-Track” status from the FDA and their lead indication has an Orphan Drug designation.
  • Culture / Environment: Work in a very collegial, fast-paced environment, which will not only gain you valuable experience, but also tremendous opportunity for internal growth/advancement.
  • Gain Tremendous Experience & Exposure: Step in and immediately work on a Phase III study and the subsequent NDA.
  • Valuable Site Management Experience: Given the highly specialized/time sensitive environment of this clinical trial, you will gain very specialized site management-level experience.

Responsibilities:

  • In close collaboration with the Clinical Trial Manager and Head of Clinical Operations (both of whom our company helped this company hire, so we know them well), ensure the efficient initiation and execution of clinical studies.
  • Lead/manage assigned sites through regular contact (in-person and via phone/email) to ensure adequate screening/enrollment, and understanding of study requirements.
  • Train study site personnel and identify opportunities to improve patient screening and enrollment recruiting activities.
  • Lead and direct study start up activities including site surveys and qualification visits and follow up with sites regarding timelines for IRB/EC approvals, budget and contracts.
  • Coordinate and attend Initiation Visits with Site Monitor and CMO to provide required training
  • Responsible for tracking and reporting study status to Clinical Trial Manager
  • Support monitoring and participate in co-monitoring as required to ensure accurate data is entered in in a timely fashion
  • Participate in regular calls and meetings with Clinical Trial Manager and Director of Clinical Operations, and any clinical team calls with CMO and CEO as required
  • Review study documents and SOPs for completeness and clarity

Skills & Experiences Sought:

  • Nursing (RN / ASN / BSN / NP) [LR2] or Physician Assistant background is required.
  • Prior CRA field monitoring experience is required.
  • Ideally 3+ years of combined experience with site management and/or CRA Field Monitoring and/or HQ-based CRA/CRC/CTM work in the pharmaceutical/biotech or CRO industries.
  • Prior CRA field monitoring experience is required.
  • Critical care experience (whether as Nurse, PA, or in industry) is a plus, but not required.
  • Vendor/CRO management experience is a plus.
  • Proven ability to build and sustain relationships with site personnel
  • Ability to travel. While our client utilizes CRO field monitors, this position is focused on building F2F relationship at the site level with PIs and Study Coordinators.

CONTACT:

Lavinia C. Rodriguez  

lcrodriguez@cornerstonesg.com

www.linkedin.com/in/laviniacrodriguez

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

Phone: 973.656.0220  

Web: www.cornerstonesg.com

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- Sr. Director, Clinical Operations Oncology

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- Sr. Clinical Trial Manager 

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