Grifols Shared Services North America, Inc Clinical Research Associate II in Dublin, Ireland
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
The Clinical Research Associate II assists in the management and coordination of clinical trials with specific emphasis on the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols.
Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study.
What your responsibilities will be
Tracks study specific tasks and progress related to the management of the trial in support of the program manager
Performs regulatory document review and approval for IP release and ethic and/or regulatory submission as required
Assists in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings).
Conducts monitor training for both internal and external monitors.
Performs remote or on-site 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.
Drafts, reviews and approves relevant documents including (but not limited to) informed consent, site worksheets, pharmacy manual, central laboratory manual and clinical monitoring plan along with the Program manager's supervision
Understands and implements processes for distribution and tracking of SAE’s, safety documentation, and pregnancies. Monitors compliance of these processes.
Collaborates with data management to resolve queries.
Facilitates investigator site payments, as applicable.
Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation.
Assists in evaluation of vendor performance during conduct of the study
Assists the program manager with oversight of third party vendors performance (e.g., CROs, central laboratories)
Reviews and approves monitoring reports for all types of site visits and contributes to review and/or approval of clinical study plans
Contributes to regular review of protocol deviations when required as well as assisting with oversight of the Trial Master File (TMF) status
Acquires a basic knowledge of the therapeutic area and product.
Obtains a complete understanding of all trial-related documents and operational procedures.
Gains exposure/participates in development of trial systems including but not limited to CRF development, CTMS, IVRS and central lab set-up, as well as other vendor selection processes.
Maintains clinical trial management system (CTMS) information pertaining to the study.
Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation).
Reviews and tracks study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.
Prepares accurate and complete meeting minutes for various meetings.
Communicates and interacts with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy.
Assists with effective and timely audit/inspection responses.
Mentors junior team members
Occasional travel involved
For studies monitored in house by Grifols, additional responsibilities may include:
Assists with drafting and reviewing of documents required for study start up (e.g. feasibility questionnaires)
Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits.
Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance.
Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
Reconciles clinical supplies and drug accountability records at study sites. 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.
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.
Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skills, education, and/or ability required.
Clinical trial management: Advanced experience in all stages of clinical trial management from the Sponsor perspective, including site selection, initiation, monitoring, and closeout visits.
Monitoring and data management: Proven expertise in monitoring and verifying data quality and integrity. Proficiency in source data verification, query resolution, and data review procedures. Familiarity with electronic data capture (EDC) systems and other clinical trial management tools.
Vendor collaboration and oversight: Advanced experience working with and overseeing vendor CRAs and other vendor stakeholders
Good clinical practice (GCP) compliance: Thorough knowledge of GCP principles and their application in clinical research.
Excellent communication and interpersonal skills: Strong verbal and written communication abilities to effectively liaise with study investigators, site staff, vendors, and other stakeholders. Capability to establish and maintain positive working relationships, resolve conflicts, and facilitate smooth communication channels.
Typically requires 5-8 years’ experience in clinical research including 3 years CRA experience within a pharmaceutical company
Organizational and time management skills: Exceptional attention to detail, organizational abilities, and the capability to manage multiple priorities within strict timelines. Proficiency in maintaining accurate and comprehensive study documentation.
Regulatory compliance: Knowledge of regulatory submission processes, including ethics committee submissions, informed consent procedures, and regulatory inspections. Familiarity with adverse event reporting and safety monitoring requirements.
Bachelors degree in relevant scientific or medical discipline
Master’s degree or higher in relevant scientific or medical discipline desirable
What we offer
It’s a brilliant opportunity for someone with the right talents.
Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We’ll help you grow professionally.
Information about Grifols is available at www.grifols.com.
If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.
We look forward to receiving your application.
Grifols is an equal opportunity employer.
Flexibility for U Program: Hybrid Model
Contract of Employment: Permanent position
Learn more about Grifols (http://www.grifols.com/es/web/international/home)
Req ID: 501965
Type: Regular Full-Time
Job Category: Clinical Trials