Job description
The scope of responsibilities will include:
Main site contact for all non-trial-participant related and non-protocol
related issues, including vendors, trial supplies and access management
Manages records flow with sites and off-site facilities
Prepares regulatory and ethics committee submission/ notification
documents and records
Coordinates payments to sites and off-site facilities
Prepares for and follows up on site audits and inspections
Reviews and coordinates site-specific query resolution with Monitors and
sites
Reviews site-specific EDC completion progress and provides the Monitor
with regular updates
Serves as the main contact point for other company departments in
administrative site-related issues
Organizes, participates in, and prepares reports of internal project team
meetings
Collaborates with sites and project team on Investigator Meetings'
organization
Under supervision, provides on-the-job coaching of Site Management
Associates I & II and Clinical Operations Administrative Support staff
Arranges and tracks initial and ongoing trial training for investigator site
teams in all vendor-related systems
Provides training in courier management and trial supplies ordering to the
investigator sites
Files trial records in the TMF and performs regular TMF checks on a site and country level
Participates in and follows up on TMF and systems audits
Prepares, distributes, and updates Investigator Site Files (ISF) and ISF
checklists
Coordinates the translation process for trial records on a site and country
level
Collects IP-REDs and compiles IP-RED packages for further review
Main vendor contact for all non-trial participant related issues, including pre-trial testing of vendor systems
Tracks vendor-related supplies on a site, country/regional level
Exchanges information and records with vendors
College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.
Minimum 3-year experience within the clinical research industry, CRO preferred, in similar role or equivalent to Site Management Associate II
Basic proficiency in MS Word.
Basic proficiency in MS Excel.
Basic proficiency in MS Outlook.
Basic proficiency in MS Power Point.
Knowledge (following proper training) of applicable software and project specific systems.
Become a full-fledged clinical research professional with the support of a knowledgeable and professional team. You will develop a variety of skills while progressing with the company and contributing to our full-scale challenging projects.
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Originally posted on Himalayas
Who can apply
Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.