CLINICAL RESEARCH ASSOCIATE (2 DAYS)
Clinical Research Associate – Pharma – Part-time
Required to set up, monitoring and follow up of assigned Clinical Trials carried out in Irish sites according to legislation, ICH GCP and company SOPs.
This is a part-time CRA role (2 days per week, maybe 3 during peak of study), with a Pharmaceutical Company based in Dublin.
Responsibilities for Clinical Research Associate:
Build and maintain relationships with study team and company medical personnel.
Identification of potential study investigators
Liaise in contract negotiations with study site.
Prepare documentation for Ethical review of assigned prospective studies in cooperation with Project Management.
Assist with regulatory submission of assigned studies in cooperation with Reg Affairs Officer.
Works according to relevant monitoring manual and update as appropriate.
Follow up of all AEs and SAEs for the duration of the studies plus 28 days after each study, as per study protocol.
Build, maintain and utilise relationships with study coordinators, investigators, ethics committees, labs and pharmacy personnel.
Requirements for Clinical Research Associate:
Bachelor’s Degree in Life Science or similar technical discipline.
3+ years’ CRA experience in similar role in Pharma or CRO.
Proven experience in; set up, monitor and close out assigned clinical trials.
Good negotiation, presentation and communication skills
Good organisational and time keeping skills
Information management and communication
Fluent English-written and verbal
Valid driving license
Please contact; Larry on 01-2302400 / [email protected] / www.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.
Key Words: Clinical Trials, CRA, Clinical Research Associate, ICH / GCP, Study Monitoring, Pharmaceuticals, Dublin, Ireland.