PSI CRO

More roles at PSI CRO

Lead Clinical Research Associate

Work from home

Remote role where the employee must remain based in a particular country.

Canada only

From the listing details: Source listing states candidate location: "Toronto, ON, Canada, Toronto, ON, ca, Remote"

Employer listed it 2 months ago · Added 2 weeks ago

Been open since 2 months ago. Long-running listings are sometimes left up after the role is filled.

Salary

$124k to $153k per year

Location

Canada only

Timezone

US East

Contract

Full-time

Experience

Lead

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: Location eligibility not confirmed
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 Canada. It is work from home rather than work from anywhere.

What the employer says

Source listing states candidate location: "Toronto, ON, Canada, Toronto, ON, ca, Remote"

What Nomaders makes of it

Residency required in Canada
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

“Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level. ”
“Must have prior experience monitoring or managing sites and CRAs with knowledge of US and Canadian regulatory guidelines and practices. ”

Written as a nice-to-have

“Strong experience in Oncology preferred.”
“Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. ”

Questions worth asking: Nomaders interpretation

The advert does not say where you can be based. Ask which countries they can legally employ or contract you from.
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 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.

Coordinates investigator/ site feasibility and identification process, as well as study startup.

Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.

Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.

Manages Monitors in the query resolution process, including Central Monitoring observations.

Coordinates safety information flow and protocol/process deviation reporting.

Performs clinical supplies management with vendors on a country and regional level.

Ensures study-specific and corporate tracking systems are updated in a timely manner.

Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.

Coordinates planning of supervised monitoring visits and conducts the visits. 

Manages the project team in site contracting and payments.

Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.

Ensures ongoing evaluation of data integrity and compliance at a country/regional level.

Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.

Oversees project team in CAPA development and implementation.

Coordinates project team in process deviations review, management and reporting.

Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.

Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.

Delivers trainings and presentations at Investigator Meetings.

Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.

Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.

Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.

Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.

Requirements

·Ability to travel up to 65% (depending on project needs).
·Valid driver’s license (if applicable).
·For this position, PSI is not hiring individuals who require work visa sponsorship for employment now or in the future.
·Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.

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 17d ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.

Listing sourced from Company boards.