Clinical Research Associate II

PSI CRO; Boston (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

PSI CRO is seeking a Clinical Research Associate to monitor clinical studies in various therapeutic indications with a focus on data integrity and compliance.

You will act as the main liaison between the project team, sponsor, and site, building strong site relationships and coordinating visits from site selection through close-out. This role requires Oncology experience, GI preferred, 2+ years on-site monitoring, and 75% travel.

Qualifications

• Bachelor's degree in Life Sciences or equivalent.
• Located in the Central or West Coast regions is preferred.
• 2+ years of independent on-site monitoring experience.
• Experience in all types of monitoring visits, in phases I-III.
• Oncology mandatory; GI preferred; radio-pharm experience preferred.

Responsibilities

• Serve as the main communication link between the project team, sponsor, and the site.
• Build and maintain relationships with site staff involved in study conduct.
• Plan, conduct, and report site selection, initiation, routine monitoring and close-out visits.
• Ensure recruitment targets are defined, communicated, recorded and met; projects timelines followed at site level.
• Manage safety data flow and protocol/process deviations with trial sites.
• Perform source data verification and manage study risks at site level.
• Handle, reconcile, and return Investigational Product and trial supplies at sites.
• Review ISF/TMF at site level and ensure quality and compliance.
• Contribute to site audits and client onsite visits as required.

Skills

English Proficiency

MS Office

Travel 75%

On-site Monitoring

Education

Bachelor's degree in Life Sciences

Tools

MS Office

Job description

Job Description

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

Qualifications:
Qualifications

• 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.

Additional Information

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.