PSI CRO
Clinical Research Associate II
Remote role where the employee must remain based in a particular country.
United States only
Employer listed it 2 days ago · Added today
First listed 2 days ago.
Salary
Not stated
Location
United States only
Timezone
US East
Contract
Full-time
Experience
Mid
Category
Other
This employer didn't state pay. Jobs like this usually pay around $90k–$165k a year, a typical range taken from 262 mid-level other roles on Nomaders that do state pay. It's a guide, not an offer.
Remote flexibility
Work from home
This is a remote role, but the employee must be based in United States. It is work from home rather than work from anywhere.
What the employer says
- Source listing states candidate location: "Remote, US, United States, Remote, US"
- Job description states: "Located in the Central or West Coast regions"
What Nomaders makes of it
- Payroll and tax are likely handled in that country only
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
About the role
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
You will:
Act as the main line of communication between the project team, sponsor, and the site
Build and maintain a good relationship with the site staff involved in the study conduct
Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level
Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites
Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level
Ensures quality (data integrity and compliance) at site level
Conduct site audit preparation visits and resolve site audit findings
Participate in study site audits and client onsite visits, as required
Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse
Conduct project-specific training of site investigators
Support preparation of Investigator newsletters
Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level
Support preparation of draft regulatory and ethics committee submission packages
Support collection of IP-RED packages at site/country level
Facilitate review and reconciliation of the study TMF on country and site levels 
College/University degree in Life Sciences or an equivalent combination of education, training & experience
Located in the Central or West Coast regions is preferred
Must have 2+ years of independent on-site monitoring experience
Requirements
- ·Ability to travel up to 75%
- ·Valid driver’s license (if applicable)
- ·For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
- ·This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.
- ·For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
Benefits
No benefits package published with this listing. Ask about it at first interview.
How to apply
- 1Check the flexibility label above, work from home, matches where you plan to live and work.
- 2Tailor your CV to the role at PSI CRO, mentioning your remote working experience and working hours (US East).
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 15h ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
Similar roles
Other open other roles with comparable remote rules.
Free to apply, no account needed.
Typically $90k to $165k per year · You'll be taken to the employer's careers page.