Clinical Project Coordinator

About the Role

To support project management in the completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budget. To comply & adhere to GCP guidelines and regulations as required of this role.

Responsibilities

• Assist in production and formatting of study documentation e.g. informed consent forms, training materials, file notes, laboratory manuals etc.
• Support set up of vendors.
• Internal risk-based monitoring following first dosing to ensure all study documentation is working effectively.
• Assist with internal data generation such as recruitment and subject status updates, adverse event summaries etc.
• Set up and host Sponsor monitoring visits.
• CRA Trial One Training.
• Ensure monitoring visit action items are addressed.
• Assist Project Managers with close out activities e.g. archiving, reconciliation.
• Manage data query resolution.
• Ongoing clinic query resolution from screening through post discharge following SDV.
• Answer queries during database cleaning.
• Action process improvement initiatives as allocated.
• Work with the study team to ensure the Investigator Site File and Trial Master Files are maintained and perform periodic QC of TMF (as per DOC-00433 Trial Master File).
• General support to the Commercial and Project Management groups as needed to win and deliver business.
• Support PM Team on Focal Point set up and invoicing.
• Support Database close and lock activities.
• SBIM (meeting minutes).
• Trial One UAT activities.

Qualifications & Experience

• Minimum Degree qualification or equivalent.
• Relevant work experience in a pharmaceutical company/CRO would be an advantage.