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Graduate Trainee Clinical Research Associate
**Job Description**:
Assists Clinical Project Manager in the management of all aspects of the daily operations of ANI TH Clinical Research Project
Manage activities of clinical investigative sites as they relate to ANI TH Clinical Research Project to ensure successful execution of the protocol on time, within budget and in accordance with country-specific regulations, ICH Guidelines, Abbott's Standard Operating Procedures (SOPs).
**Major Responsibilities**:
- Conduct site qualification, initiation, remote and interim monitoring and study closeout visits in accordance with the protocols, applicable regulatory guidelines, Good Clinical Practices (GCPs), ICH Guidelines, and Abbott Nutrition (AN) Standard Operating Procedures (SOPs) and business processes.
- Set up study site management in Clinical Trial Management System (CTMS). Collect and manage essential documents for assigned study sites.
- Conduct all clinical site activities per the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:
- Manage the activities of clinical investigative sites across multiple protocols.
- Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Collect and upload into Share-point critical documents & maintain Permanent Study Files for assigned sites throughout the life of the trial. Prepare, review, submit to second reviewer and sign-off on Essential Documents Packages (EDP).
- Perform on-site product inventory count and for unblinded studies compare to site’s product inventory records to identify any discrepancies.
- Prepare and make IRB submissions for sites, as needed.
- Train study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
- Ensure regulatory inspection readiness at assigned clinical sites.
- Report monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.
- Interact and build professional and collaborative relationships with all study personnel (investigator, study coordinator), peers and office-based personnel. Use multiple technologies to maintain open and frequent communication with Abbott personnel.
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