In-House Clinical Research Associate II / Senior In-House CRA - Remote

Overview

The In-house CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), and country/region-specific regulations). Acts as point of contact for study sites. The In-house CRA ll is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

In Short

• Assist with investigator recruitment activities.
• May assist in identifying study sites.
• Schedules internal and external meetings as required.
• Prepares Investigator Site Files.
• Performs ongoing essential document collection and review.
• Assists with setting up and maintaining site-related data.
• Acts as site contact/liaison for study and site management issues.
• Ensures timely and complete data entry by site.
• Sends email blasts/newsletter to study site personnel.
• Supports investigators and investigative staff.

Requirements

• Bachelor's degree or equivalent in a business, scientific or healthcare discipline.
• Minimum of 2 years of relevant experience.
• High proficiency in Microsoft Office.
• Customer service demeanor; demonstrate flexibility and teamwork.
• Attention to detail and accuracy.
• Fluency in English communication.
• Working knowledge of the drug development process.
• Ability to travel as needed.

Benefits

• Eligible for a discretionary annual bonus.
• Health insurance.
• Retirement savings benefits.
• Life insurance and disability benefits.
• Parental leave.
• Paid time off for sick leave and vacation.