Clinical Data Associate

The role

Perform assigned data management tasks, under supervision, on clinical studies or research projects within the clinical trial environment. Responsible to ensure completion of tasks, within agreed timelines and in accordance with Harvest Integrated Research Organization’s (HiRO’s) contractual obligations and Standard Operating Procedures.

This role is home-based in Romania.

Key Responsibilities:

Perform the following tasks under supervision of a more senior data management team member:

Study Setup

• Review clinical trial level documentation (eg protocol) and data management (DM) trial level documentation (e.g. DMP, validation specifications)
• Support maintenance of DM trial level documentation (e.g. CCGs, validation specifications)
• Support User Acceptance Testing and completion of associated documentation

Study Conduct and Close-out

• Perform data review and query management activities
• Support receipt and perform reconciliation of third-party data
• May perform simple SAE reconciliation
• Support the receipt, management, entry, QC and review of local laboratory reference ranges
• Support EDC User management activities
• Provide support for study data and DM documentation archiving

General

• Ensure accurate maintenance and filing of study documents
• Ensure timely and accurate entry of time into timesheet
• Maintain awareness of study timelines and follow up any issues that affect these or the quality of the data.

Required skills and qualities

• Batchelor’s degree level qualification in a scientific discipline is preferred.
• Experience in using Microsoft Office
• Fluent English: Read, Written, Spoken

What we offer:

• Mentorship and training to develop your skills in the clinical trials industry
• The chance to be part of an effective, dynamic, friendly, and supportive team
• Work with new and exciting technologies
• Development opportunities