Senior CRA, Clinical Trial Specialist
|Contact Name:||Larry O’Leary|
Our client is focused on the discovery, development and commercialization of novel antibodies that are directed towards rare diseases. Rapid expansion has led to the need to create the appointment of an EU-based Clinical Trials Specialist, to be based in their Dublin office and operating as part of a global team.
This is a rare opportunity to join a young, exciting clinical-stage biotechnology company who are growing year-on-year.
Please note: this role is an initial 12 month fixed term contract role. Candidates must be willing to travel circa 20 - 25% at a maximum, the majority of which is within EU region.
The main focus of this role: is to work closely with various internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.
Responsibilities of Senior CRA, Clinical Trial Specialist:
Assists with the study project plan development/review, including timeline and budget
Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
Assist with protocol, CRF and strategy development, Clinical Study Report preparation, NDA submission, etc.
Interacts with investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study sites
Performs manual, in-house review of CRF data in clinical database for completeness and accuracy
Prepares metrics and updates for internal review, as assigned
Proactively identifies potential study issues/risks and recommends/implements solutions
Participates in and facilitates CRO/vendor selection process for outsourced activities
Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Lab Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
Manages clinical monitoring activities ensuring compliance with GCP and applicable regulations
Participates in the development, review and implementation of departmental SOPs and processes
Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
Reviews site study documents, investigator contracts, and site payments
Participates in the selection, training and evaluation of study personnel to ensure the efficient operation of function
Requirements for Senior CRA, Clinical Trial Specialist:
Bachelor of Science degree is preferred.
3+ years of related clinical trial management experience (e.g. CRA, study coordinator) in the pharmaceutical industry or clinical setting.
Experience in managing outside vendors, e.g., CROs and other vendors.
Rare Disease and/or Oncology experience preferred.
Strong knowledge and experience of clinical research operations, including interpretation and implementation of EU regulations/ICH guidelines, is required.
Ability to provide clinical expertise to a clinical development in a specified product area or project.
Candidate will be a superb communicator of technical and scientific information and possess excellent interpersonal skills & strong organization skills.
Must display strong analytical and problem solving skills. Strong attention to detail is required.
Please contact Larry on +353 1 - 2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Follow us on Twitter, Facebook and LinkedIn