Clinical Research Associate

Clinical Research Associate

Grifols

Dublin, Ireland

POSITION SUMMARY:

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.

What you'll do:

• 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 a good knowledge of the therapeutic area and product.
• Obtains a complete understanding of all trial-related documents and operational procedures with moderate direct supervision

Audits/Inspections/Quality Assurance (QA):

• Supports with effective and timely audit/inspection responses.

Clinical Trial Design/Performance:

• 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 (PSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs), to determine protocol and regulatory compliance.
• Contributes to the resolution of escalated issues from study centers, regulatory authorities and institutional review board (IRBs)/independent ethics committees (IECs) with the support of the supervisor, if needed.
• Performs Sponsor Site Visits at selected sites to demonstrate oversight of the monitoring process and documenting the visits in the Sponsor Site Visit Report.
• Oversees study centers to ensure timely execution of the clinical studies, generating quality data ensuring the well-being of the study subjects and the trial integrity with moderate supervision.
• With the support from the supervisor, may support in the creation, review and tracking of study documents.
• May assist on the TMF reviews and resolution of findings, internally or interacting with the CRO with support if needed.

Clinical Trial Materials (CTM):

• Provides support on the regulatory document review and approval for investigational product (IP) release.
• Provides support in clinical product technical complaints and product recall as necessary.
• Provides support and information to the CTM staff regarding IP management, as needed.

In-house Monitoring:

• May assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
• May facilitate investigator site payments, as applicable.

Management/Training Team:

• Ability to facilitate meetings (e.g. Investigator Meetings, Kick-off meetings).
• May provide support for the monitor training and contribute to resolve the issues they identified.
• Collaborates in ensuring that appropriate training is conducted for CRO staff, vendors, investigators, and study site staff on study requirements and internal SOPs (if applicable).

Monitoring:

• Reviews and tracks comments of monitoring reports generated by the vendor (i.e. CRO) as part of Sponsor Oversight of Vendor Clinical Site Monitoring activities.
• With the support of the supervisor, if needed, verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
• Tracks study specific tasks and progress of the trial.
• Gets more insight, maintains and updates clinical trial management system (CTMS) information pertaining to the study.
• Is involved in the oversight of vendor clinical monitoring activities. Ensures that the clinical monitoring process is done in adherence to an international ethical and scientific quality standard to provide public assurance that the clinical data are credible.
• May collaborates with data management to resolve queries.

Vendor Management:

• Assists in the management of vendor performance during conduct of the study with moderate direct supervision.
• Assists in evaluation of vendor performance during conduct of the study.
• Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation, with moderate supervision.
• Facilitates the scheduling of internal team meetings, cooperating with defining the agenda and creating the meeting minutes, if needed.

Additional On-site Monitoring Responsibilities:

In-house Monitoring:

• Performs monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.
• Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits.
• Reconciles clinical supplies and drug accountability records at study sites.
• Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
• Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
• Reviews, clarifies, and obtains, data changes via query resolutions with site personnel.
• Conducts completion of PSVs, SIVs, IMVs, and COVs, to determine protocol and regulatory compliance.
• Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study.

Monitoring:

• Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.

Safety:

• Understands and supports implements processes for distribution and tracking of SAE’s, safety documentation, and pregnancies. Monitors compliance of these processes.

What you'll bring

• Typically requires 2 years of experience in clinical research, including a minimum of 1-year field monitoring experience (e.g., independent monitoring, co-monitoring, accompanied site visits).
• Associate’s degree in a life science field required.
• Relevant experience in clinical research and field monitoring experience preferred (e.g. independent field monitoring and co-monitoring).
• 4 years clinical research experience with 2 years experience as a CRA.
• Bachelor’s degree or higher degree in a life science field preferred.