Clinical Research Associate II

This is a fully remote position, open to applicants in United States.

📋 Description

• Serve as the primary point of contact between the project team, sponsor, and the site.

• Foster and maintain strong relationships with site staff involved in the study execution.

• Prepare, execute, and report on site selection, initiation, routine monitoring, and close-out visits.

• Ensure that subject recruitment objectives are clearly defined, communicated, recorded, and achieved, while adhering to project timelines at the site level.

• Guarantee accurate and prompt information exchange regarding Adverse Events and protocol/process deviations with trial sites.

• Conduct source data verification and address data queries at the site level; assess and manage study risks at the site.

• Ensure appropriate handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies at the sites.

• Review essential study documents and reconcile the Investigator Site File (ISF) / Trial Master File (TMF) at the site level.

• Ensure quality (data integrity and compliance) is maintained at the site level.

• Conduct site audit preparation visits and address findings from site audits.

• Participate in study site audits and client onsite visits, as necessary.

• Facilitate the flow of documents and study supplies between the project team, site, and the Central/Regional Laboratory/Central Reviewer/Warehouse.

• Provide project-specific training for site investigators.

• Assist in preparing Investigator newsletters.

• Support Site Management Associates in maintaining study-specific and corporate tracking systems at the site level.

• Aid in the preparation of draft regulatory and ethics committee submission packages.

• Assist in the collection of IP-RED packages at the site/country level.

• Facilitate the review and reconciliation of the study TMF at both country and site levels.

⛳️ Requirements

• Bachelor's degree in Life Sciences or a comparable combination of education, training, and experience.

• Preference for candidates located in the Central or West Coast regions.

• A minimum of 2 years of independent on-site monitoring experience is required.

• Experience in conducting all types of monitoring visits during phases I-III.

• Experience in Oncology is essential; experience in Gastrointestinal (GI) and/or radio-pharmaceuticals is preferred.

• Full professional proficiency in English is required.

• Proficient in MS Office applications.

• Capable of planning, multitasking, and thriving in a dynamic team environment.

• Valid driver’s license (if applicable).

🏝️ Benefits

• This position offers an excellent opportunity to enhance your skills, broaden your therapeutic area experience, and become a specialist in clinical research.