Clinical Research Associate II Job at PSI CRO, Remote

dnNjQ0M2NE43eVhqMm9PRytsdXFZNjZSQlE9PQ==
  • PSI CRO
  • Remote

Job Description



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.

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

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • Located in Central or West Coast preferred
  • 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)

 

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.

Job Tags

Full time, Contract work, Work visa,

Similar Jobs

Penumbra, Inc.

Medical Device Quality Electrical Engineer II Job at Penumbra, Inc.

 ...Job Description General Summary The Quality Electrical Engineer II develops and implements appropriate quality system elements...  ...recommended, medical device industry preferred Experience with Electronic devices and or PCBAs Excellent verbal, written, and... 

Remote Career

Work at Home Data Entry Clerk - Part Time Job at Remote Career

About the job Work at Home Data Entry Clerk - Part TimeNOTE: Only for US residenceGain cash from Home by Participating in Paid Surveys - Data Entry clerks - Customer Service Rep - Part-timeWe are searching for individuals nationwide to take part in paid studies -... 

Tibbott & Richardson

Experienced Legal Billing Specialist Job at Tibbott & Richardson

 ...Job Description In-office position Are you an experienced Billing Specialist seeking an opportunity at a growing law practice in Wexford...  ...seeking a proficient professional with a strong aptitude for legal billing and a passion for collaborative work environments.... 

Adam Hergenrother Companies

Real Estate Agent Job at Adam Hergenrother Companies

 ...We are the company of the future. The real estate market is one of the hottest we've seen in...  ...and well help you get you started. Be a part of one of the most innovative real estate...  ...for more information. Job Types: Full-time, Part-time, Contract Salary: $30,000.0... 

Aequor Allied

Travel X-Ray Technician Job at Aequor Allied

 ...Job Description Aequor Allied is seeking a travel X-Ray Technician for a travel job in Morristown, New Jersey. Job Description & Requirements ~ Specialty: X-Ray Technician ~ Discipline: Allied Health Professional ~ Start Date: 08/04/2025~ Duration: 13...