Radius Health, Inc.

Clinical Research Associate (CRA/In-House)

US-MA-Waltham
3 weeks ago
Job ID
2017-1622
# of Openings
1
Category
Clinical Development

Overview

Note: This is an onsite/in-house sponsor side CRA position.

The in-house Clinical Research Associate (CRA) will assist the clinical operations project lead and the clinical team in day to day activities for managing clinical study conduct per project team objectives. The ideal candidate will have keen attention to detail and has the ability to both prioritize and handle multiple tasks effectively in a rapidly growing company environment. The CRA will support the development programs for the investigational drug product candidate RAD1901 and/or abaloparatide.

The CRA will be expected to participate in the processing and performance of quality assurance checks of clinical trial data to ensure data integrity and consistency across clinical programs and in accordance with Radius standard operating procedures and Good Clinical Practices (GCP).  

Responsibilities

  • Ability to lead day to day support of study operations, including tracking and creating overviews of subject, site, study status, milestones and performing quality check activities across components of the clinical study and in conjunction with the CRO and other project associated vendors.
  • Performs verification and quality control of essential regulatory documents and is well versed in the organization of a trial master file.
  • Oversee clinical monitoring activities outsourced to CRO/or contract CRAs; Co-monitors or performs sponsor visits to the study sites with the assigned CRAs as required; Reviews, comments & documents monitoring visit report reviews and escalates issues to clinical operations project lead as appropriate.
  • Creates & maintains study specific tracking tools and project files as needed.
  • Assist in managing investigational product supplies at the country (where applicable) and trial site level, keeping sites informed of drug lots/batches and expiration dates. Ability to review and perform drug accountability if required.
  • Ability to navigate EDC systems and review data as needed to meet project objectives.
  • Assist in the preparation of site and in-house Sponsor inspections.
  • Maintain/develop a good level of scientific knowledge within the Project’s therapeutic area.
  • Effectively communicates with study team members and works closely to address challenges.
  • Participates in the set-up of the clinical database (UAT testing).
  • Knowledgeable about IWRS systems.
  • Assist with NDA activities as needed.
  • Helps to identify, create & establish study tools for department
  • Consistently performs duties within established Standard Operating Procedures, and in accordance with Good Clinical Practices.

Qualifications

  • Required Bachelor’s degree, in a health science related field is preferred
  • 3-4 years of clinical trial management experience at a CRO or Pharmaceutical company with at least 2 years of on site clinical trial monitoring experience is preferred.
  • Oncology experience a plus.
  • Solid understanding of study trial design, trial execution and operations (including creating study tools).
  • Excellent computer skills (Microsoft Office Word, Excel, Outlook) required.
  • Good organizational & time management skills
  • Willingness to work in a flexible environment
  • Sound working knowledge of knowledge of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and other applicable regulatory guidelines required.
  • Global trial experience a plus.
  • Some travel required (as needed basis; not continuous).

 

 

 


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