Line Manager of Junior CRAs for vaccines protocols
Perform Accompanied Site Visits, on site and remotely with
appropriate reports, for the oversight of assigned CRAs; confirming the Monitoring visits and
reports are performed with quality.
Review of weekly Timesheets, confirming tracked hours are in
accordance of the FTEs of the assigned protocols for the CRAs.
Oversight of CRAs Sponsor Training Compliance, CRO SOPs and follow up.
Participation of new hires interviews.
Development of CRAs skills.
One on one meetings with assigned CRAs.
Participation on Year Performance Review of assigned CRAs
Review of Visit Reports.
Perform Internal Line Group Meetings with assigned CRAs.
Participation as presenter on Regional Site call
Work with sites and assigned CRAs as main point of contact of
the Country; being also the main support for the Regional Clinical
Lead, performing site and CRA training and oversight
Bachelor's Degree Degree in scientific discipline or health care preferred. Req
Requires at least 4 years of year of on-site monitoring experience.
Equivalent combination of education, training and experience may be accepted in lieu of degree.
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Strong therapeutic and protocol knowledge as provided in company training.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
Written and verbal communication skills including good command of English language.
Organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.