The Company

At Headlands Research, we are building the best clinical trial company in the world. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, our company is in high growth mode; we operate 15 clinical trial sites in the US and Canada and have rapid expansion plans.

This new Clinical Research Coordinator role is a full-time position and will be based in Orlando, FL                                                                                                                                        

The Role

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Principal Investigator.   The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. 

 

Essential Functions

  • Participate in the coordination of multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) in support of activities that meet objectives of assigned research protocol(s).
  • Assesses patients for protocol eligibility and communicates findings to Principal Investigator.
  • Coordinates the implementation of protocol procedures.
  • Assesses and monitors patient responses and adverse reactions; reports same to accountable sources.
  • Provides appropriate patient and family education.
  • Completes a variety of reports, documents and correspondence for regulatory agencies, participating clinical trial sites and for internal purposes.
  • Collaborates with Principal Investigator and study team to ensure adherence to FDA and protocol guidelines; identify potential problems and/or inconsistencies and act as appropriate.
  • Assist in the preparation and submission of amendments to clinical trials protocols to the IRB.
  • Provides educational in-services as needed.
  • Promotes interdepartmental cooperation and coordination for each protocol.
  • Maintains reasonably regular, punctual attendance consistent with Headlands Research policy.


Qualifications

  • Experience and training in conducting clinical trials with knowledge of ICH GCP
  • Bachelor’s degree in a health or scientific related program
  • A thorough understanding of regulatory requirements
  • 2+ years previous experience working in a clinical setting
  • Ability to manage up to 6 clinical trials concurrently
  • Excellent written and verbal communication skills
  • Ability to interact effectively with professional, administrative staff, sponsor and regulatory representatives, participants and referral sources
  • Superior organizational and time management skills
  • Bachelor’s degree in a health or scientific related program
  • Capable of working independently with minimal supervision and also as part of a team
  • Ability to speak a second language is an asset, but not required
  • Understanding of medical terminology as well as standard clinical procedures and protocols
  • Prior experience training and mentoring staff members is preferred
  • Experience with CRIO (Clinical Trial Management System) is a plus