Clinical Support Specialist (RTP BioPharma) – Direct Hire (To $55/60k)

Job Type: 
Life Sciences
Other Life Science Positions
Employment Category: 
Direct Hire

Our client, an RTP-area biopharmaceutical company that is developing immunotherapies to fight cancer and other diseases, is actively recruiting for a very organized, capable and industrious candidate to assume a key support role on its Clinical team.  This Clinical Support Specialist will provide broad-reaching support to internal teams and assigned clinical research sites.

We seek a go-getter who gets things done.

Key things to note:

  • This company is building.  It has multiple products in development and is aggressively pursuing targets for its proprietary technology.  The future is very bright.
  • The company is developing immunotherapies to treat various cancers as well as infectious disease (including COVID) and other ailments.  Experience in immunotherapy and/or oncology will be a plus
  • This CSS will report to the Clinical Project Manager and support all phases of development.  He/she will be located at the home office and work with both internal personnel and sites to track activity, provide information, maintain files, etc.  Seek strong administrator with familiarity with all aspects of Clinical Research Operations.
  • This is small company in building mode. It is a roll-up-your-sleeves environment where everyone contributes broadly. Seek skilled, versatile and committed candidate who enjoys being in the middle of it all.
  • This role is office based in the RTP, NC area, and COVID precautions are strictly enforced.  There may be flexibility to work from home, once trained.

Specific duties will include:

  • Serve as clinical and administrative support for assigned clinical teams
  • Assist investigative sites with completion and submission of all required clinical trial documents prior to site initiation
  • Responsible for investigation product shipment authorization and checklist review
  • Track, update and maintain clinical trial activity in CTMS, to include reconciliation between CTMS and other systems
  • Maintenance Trial Master File for clinical trials, to include Study and Site level reviews.  Assure essential documents are audit / inspection ready
  • Involved in the coordination Institutional Review Board/ Ethics Committee (IRB/EC) and Institutional Biosafety Committee (IBC) approvals
  • Responsible for attending clinical trial team meetings, preparing clinical team meeting agendas and minutes, as well as reviewing and sharing team and investigator site communications
  • Coordinates the procurement of all equipment/supplies provided to investigative sites, to include tracking and reporting
  • Work closely with investigative site staff and vendors, to include tracking and executing Investigator payments, as well as 3rd party vendor account set up, invoice review and assistance

Targeted candidate will offer a BA/BS degree and 1 year of clinical support experience in a Pharma, Biotech or CRO. 

Other priorities include:

  • Experience supporting a clinical team conducting clinical trials
  • Understanding of ICH/Good Clinical Practice (GCP) guidelines, CFR requirements and federal regulations will be important
  • Proficiency in clinical trial computer software databases and systems (CTMS, EDC, ETMF)

Finally, we seek a motivated self-starter who can take initiative.  An independent, knowledgeable and flexible professional who will work exceedingly well in a dynamic and collaborative setting; One who can adapt to changing priorities and one who has the ability to take initiative to complete tasks under tight deadlines.

Client is open to Direct Hire or Long-Term Contractor candidates.

This is an immediate need.  Please forward Word resume for prompt consideration.  Local candidates only.