Senior CRA, Biopharma

Job Title: Senior CRA, Biopharma
Contract Type: Permanent
Location: Dublin
REF: 124213
Contact Email:
Job Published: over 1 year ago

Job Description

Senior CRA, Biopharma
Our client, a young clinical stage biopharmaceutical, now have approved a full-time permanent role of Senior Clinical Research Associate operating as part of Global Clinical Operations team and based in Ireland and able to travel to Dublin office when necessary. Note: this role requires high level international travel.

As a key member of the Clinical Operations team, this hire with provide sponsor oversight of all the Clinical Operational activities for Phase I-III Global Clinical Trials to meet regulatory guidelines and close-out timelines and budgets.

The Senior CRA will assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and ensures clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor SOPs, ICH-GCP and relevant regulatory guidelines.

Responsibilities of Senior CRA:
In conjunction with Clinical Ops team, 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.
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 internal team meetings, investigator meetings and other trial-specific meetings.
Reviews site study documents, investigator contracts, and site payments

Requirements for Senior CRA:
Bachelor of Science Degree. Advanced qualification is preferred.
4+ years' Clinical Operations experience across Phase I-III trials in either CRO or pharmaceutical company, with progression from Study Coordinator to CTA to CRA / Senior CRA.
Experience in managing outside vendors, e.g., CROs, Labs, and other vendors is preferred.
Broad therapeutic experience, including complex studies in Rare-diseases, CNS, etc.
Strong knowledge and experience of clinical research operations, including interpretation and implementation of EU regulations, ICH/GCP guidelines, is required.
Fully conversant with the use of EDC, CTMS, IRT, eTMF, clinical databases, etc. in clinical trials.
Ability to provide clinical expertise to 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.
International travel is required (~80%); across mainland Europe and US.
Multilingual is advantageous.

For further details, please contact Larry on +353 1 – 2302400 /

The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.

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