PSI CRO
More roles at PSI CROClinical Research Associate II
Remote role where the employee must remain based in a particular country.
United States only
From the listing details: Source listing states candidate location: "Remote, US, United States, Remote, US"
Employer listed it 3 weeks ago · Added 3 weeks ago
Been open since 3 weeks ago, still being checked, but it has been live a while.
Salary
Not stated
Location
United States only
Timezone
US East
Contract
Full-time
Experience
Mid
Category
Other
The employer did not publish a salary, and we have too few comparable roles to estimate one.
What the advert says
Quoted word for word from the employer's advert. Where it says nothing, we say so.
- Working hours
- Not mentioned in the advert
- Where you can work from
Participate in study site audits and client onsite visits, as required
- Contract
- Not mentioned in the advert
- Experience asked for
- Not mentioned in the advert
- Pay
- Not mentioned in the advert
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.
Before you apply
Experience: employer states
Written as a requirement
- “Must have 2+ years of independent on-site monitoring experience”
Written as a nice-to-have
- “Experience in Oncology mandatory & GI preferred and/or radio-pharm experience preferred.”
Questions worth asking: Nomaders interpretation
- No pay is stated. Ask for the salary range before investing time in interviews.
- The advert does not say whether this is employment or a contractor arrangement. Ask, as it affects tax and benefits.
Produced automatically from this advert's text; not reviewed by a person. The employer's own page is the final word.
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 21d ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
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