Clinical Research Associate II

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

Experience in all types of monitoring visits, in phases I-III

Experience in Oncology mandatory & GI preferred and/or radio-pharm experience preferred.

Full working proficiency in English

Proficiency in MS Office applications

Ability to plan, multitask and work in a dynamic team environment

Communication, collaboration, and problem-solving skills

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.
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.
Originally posted on Himalayas