Senior Clinical Research Associate
|Contact Name:||Larry O’Leary|
Our client, a blue-chip pharmaceutical company based in Dublin, now seeks Senior CRA to ensure ICH GCP, company SOPs and regulatory requirements of clinical research to ensure adherence of all parties involved in the study conduct.
The successful candidate will act as key liaison person between site personnel and the sponsor by fostering good relationships, raising the company profile and achieving trial goals.
This is a for a 12 month contract role; who can be hired on RFT Groups payroll as either as PAYE contract or self-employed basis (with necessary tax clearance certificate).
Responsibilities for Senior Clinical Research Associate:
Perform on-site or remote monitoring to oversee and ensure adherence to protocol, regulatory requirements, company SOPs/WIs and ICH GCP:
o Reviews study requirements; conduct pre-trial visits to assess & evaluate sites ability to deliver trials as required
o Manage, train and motivate study site staff from initiation, to ensure fulfillment of trial commitment with respect to recruitment, data, quality and trial progress.
o Verification of study data and management of data flow including timely resolution of queries.
o Monitor and ensure effective oversight of site's management of IMP from delivery to destruction.
o Contribute to monitoring of patient safety reporting all adverse events and events of special interest.
o Monitor and reconciliation of the Investigator Study file including collection of documentation for in-house master file.
o Identify issues and study non-compliances, ensure corrective and preventative actions are outlined and implemented at site and escalate where required in line with company SOPs /WIs.
o Timely completion and submission of study related reports along with essential documents following each visit.
o Successful close out of investigational site following completion of the study
Ongoing communication with the CML to liaise on study conduct, progress at allocated sites.
Manage and organise own work load with ability to prioritise trials based on deadlines and trial milestones, in line with department objectives.
Share best practices with line manager and clinical team to help and achieve team goals.
Seek and obtain training to build competency in company systems, therapeutic knowledge, company products and technical aspects of studies.
Requirements for Senior 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 +353 1-2302400 / email@example.com / 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, Galway, Connaught, Midlands, Leinster, Dublin, Ireland.