Clinical Research Associate
I am recruiting for a Clinical Research Associate for a multinational pharmaceutical, they are a European leader and one of the largest globally in their field.
Clinical Research Associate
The role: Assist in the clinical trial management to ensure timelines and metrics are met and maintained throughout the study. Provides support in the oversight and management of vendors. Conducts review of clinical data to ensure site adherence to applicable regulatory requirements, International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, company standard operating procedures (SOPs), and study protocol.
Location: Dublin, Ireland.
Salary: Excellent salary, bonus and benefits available. Contact John Finn for more information.
* Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH GCP Guidelines, company SOPs, and study protocols. Ensure timelines and metrics are met and maintained throughout the study.
* Has excellent knowledge of the therapeutic area and product.
* Obtains a complete understanding of all trial-related documents and operational procedures with limited direct supervision.
* Helps provide effective and timely audit/inspection responses.
* Gains exposure/participates in case report form (CRF) development, interactive "X" recognition system (IXRS) set-up, central laboratory (lab) set-up, and other vendor selection processes and is capable of training others.
* Oversees completion of Pre-Study Visits (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV), to determine protocol and regulatory compliance.
* Contributes to the resolution of escalated issues from study centres, regulatory authorities and institutional review boards (IRBs)/independent ethics committees (IECs). Oversees study centres to ensure timely execution of the clinical studies.
* Performs Sponsor Site Visits at selected sites to demonstrate oversight of the monitoring process and documenting the visits in the Sponsor Site Visit Report.
* Conduct regulatory document reviewal and approval for Clinical Trial Materials (CTM). Provide support and information to CTM for IP management and clinical product technical complaints.
* Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
* Maintains and updates clinical trial management system (CTMS) information pertaining to the study. Responsibilities include tracking trial progress, continuous monitoring of vendor reports and study document verification. Collaborates on TMF reviews and resolution of findings with support, if needed.
* Oversees vendor clinical monitoring activities. Ensures that the clinical monitoring process is done in adherence to an international ethical and scientific quality standard.
* Assists in the management and evaluation of vendor performance during conduct of the study with limited supervision.
* On-site monitoring/co-monitoring activities for PSVs, SIVs, IMVs, and COVs, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies. Prepare follow-up reports
Your knowledge and experience:
* Bachelor's degree or higher degree in a life science field preferred.
* Typically requires 2-5 years of experience in clinical research, including a minimum of 1-2 years field monitoring experience and experience in lead CRA role.
* Relevant experience in clinical research and field monitoring experience preferred (e.g. independent field monitoring and co-monitoring).
If you are interested in this Clinical Research Associate position please contact me through LinkedIn or directly to arrange a confidential follow up call: 01 645 5222, Mobile: 087 621 4254, firstname.lastname@example.org