Job Description
Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research, now has a newly created Clinical Trial Associate role based in their Dublin office. This is a full-time permanent role with good opportunity for progression.
The successful candidate will work with clinical operations team to support the execution of the deliverables for global clinical studies, supporting vendor management and vendor relations as delegated by study management.
Responsibilities of Clinical Trial Associate:
Tracking of study deliverables with escalation of key issues/trends.
Participate in overall study planning and set-up activities.
Support team administrative needs as warranted, meeting minutes and updating key decision logs
May assist in the design, format, review and content of study guides, worksheets, quick reference cards and other materials/documents used to support the study
Tracking and routing CDA’s and contracts as applicable
Submit documents to TMF, in the absence of CRO
Track essential documents, screening and enrollment progress, CRF flow and data query resolution in the absence of CRO or hybrid
Receive, Track and Process Medical Review Forms (MFRs)
Report Management and Distribution as needed (Safety, Listings etc.).
Assist with IRB Essential Document tracking
May assist with ICF review, compare against approved template
May assist with the quality control of clinical data for clinical study report preparation
Attend and contribute to vendor/CRO/team meetings and work with vendors to help resolve issues and foster process improvements
Assist CRSM with meeting Agenda and maintain Minutes for internal team meetings
May contribute to development of recruitment strategies and materials
Work with PKDM/Specialty Labs to help coordinate shipment and analysis of samples as needed
Help coordinate Investigator Meeting, CRA workshops, and other vendor meetings as applicable
Requirements for Clinical Trial Associate:
Third level qualification in Scientific or related discipline.
1-2 years of clinical research, ideally some of which in pharmaceutical industry or with CRO.
Experience with supporting clinical studies ensuring compliance with ICH, GCP and applicable international regulations and guidelines.
Ability to write, present and articulate clearly on scientific and clinical issues.
Proven ability to work in global team matrix and deliver project goals
Please phone Larry on +353 1-2302400 / larry@rftgroup.ie
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
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