At Grifols, 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.

POSITION SUMMARY:

Provides administrative/clinical support on assigned clinical projects/programs to ensure needs are met within timelines established.

What you'll do:

• Assists the clinical team in daily study operations.
• Communicates with internal and external customers to increase project and departmental efficiencies
• Coordinates the scheduling of internal team meetings, cooperating with the drafted agenda and creating the meeting minutes. May also present during the meetings.
• Coordinates logistics of study related meetings including medical expert meetings, investigator meetings, and kick off meetings. Assists in project travel plans, reservations, and expense reports, specific to meetings wherein they were responsible for.
• Maintains project related trackers and provides this information to the rest of the study team as needed.
• Maintains clinical trial management system (CTMS). Creates studies within the system per standard operating procedures (SOPs), tracks study specific data, and generate reports.
• Assists in the preparation, creation and quality review of key clinical study documents such as informed consent documents, essential regulatory document requirements, study manuals, investigator brochures, protocols, clinical study reports and, at start-up, may review and check investigational product (IP) release documents.
• Assists in the distribution of key clinical study documents such as investigator brochures, protocols, informed consents, and regulatory submissions.
• Follows up on study progress and coordinate updates and/or retrieval of appropriate regulatory documents throughout the study.
• Submits and tracks essential documents to the Trial Master File (TMF) on an ongoing basis.
• Assists in the archival of clinical research organization (CRO) study files.
• Coordinates the set-up, filing, maintenance, and periodic review of TMF and project electronic filing system throughout the study.
• Collaborates with other departments and vendors, if needed, on the review and maintenance of the TMF.
• Performs the filing, maintenance, and periodic review of project TMF throughout the study in case the task has not been delegated to a vendor.

What you'll bring

Qualifications

• Associate’s degree in life science field preferred
• 2 years of experience as a clinical trial associate

Desireable:

• 4 years of experience as a clinical trial associate
• Relevant experience in clinical research

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates are (3%/ 5%/ 7%) and company will match
• Private Medical Insurance for the employee
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness activities - Social activities eg. Padel, Summer Events

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you

#LI-FD1

Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3

Learn more about Grifols