Job Description
Our client is a fast-growing biotech company based in Dublin with an exciting drug development pipeline, now has a newly created permanent role of Clinical Trial Specialist. This role will support a global clinical program, with oversight and partnership with CRO and other such vendors.
The role will be based in Ireland and require extensive travel across Europe (circa 50-75%).
The successful candidate will work within a global team supporting clinical operations activities and provide clinical expertise to the delivery of clinical study projects - support vendor/CRO relations and activities.
The main focus of this role: is to work closely with Clinical Project Managers and 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 Clinical Trial Specialist:
Providing support to sites in in trial startup activities and training of procedures.
Establishing regular lines of communication with the sites and the CRAs.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Create and maintain appropriate documentation regarding site management and trial execution.
Collaborate and liaise with study team members for project execution support as appropriate.
Assists / support CRO interactions, 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.
Prepares and/or reviews/updates study-related documents (e.g., Monitoring Plan, Lab Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines).
Assist / support clinical monitoring activities ensuring compliance with GCP and applicable regulations.
Supports internal team meetings, investigator meetings and other trial-specific meetings.
Requirements for Clinical Trial Specialist:
Bachelor's Degree in scientific discipline or health care preferred.
2+ years’ experience in a healthcare / clinical setting, ideally experienced in Pharma/Biotech/CRO company.
Good knowledge and experience of clinical research operations, including interpretation and implementation of relevant regulations and ICH GCP guidelines, are required.
Experience with clinical trial management systems, e.g., Docusign, Veeva Vault, etc.
Excellent communicator of technical and scientific information, including good command of English language and possess excellent interpersonal skills.
Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint.
Strong attention to detail and ability to multitask is required.
Organizational and problem-solving skills.
Willingness to travel between 50-75% to sites across Europe.
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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