Clinical Project Coordinator

Quotient Sciences•Miami, FL

23d

About The Position

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.

Requirements

Minimum Degree qualification or equivalent

Nice To Haves

Relevant work experience in a pharmaceutical company/CRO would be an advantage

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.