Clinical Research Associate II

2 days ago

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Description

• Travel to sites conducting clinical trials to ensure all activities are in compliance with the protocol, federal regulations and ICH-GCP (Good Clinical Practice) guidelines. • Conduct monitoring visits including: Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits. • Oversee drug accountability, storage and disposition at investigative sites. • Collect and maintain investigator regulatory documents. • Conduct Site Endpoint Evaluation Visits when required by contract. • Ensure proper maintenance of required records for monitoring activities and required regulatory documents per CPC requirements. • Help produce study materials, including Case Report Forms, Study Procedure Manuals and source documents. • Assist with the selection of qualified sites and investigators for participation in research protocols. • Develop and present materials for investigator meetings and sponsor/CRO training. • Provide training to other CRAs as well as to staff at selected research sites.

Requirements

• Nursing or bachelor’s degree preferred but not required. • Minimum of three years of experience in clinical trials research. • At least one year experience as a CRA. • Demonstrated mastery of CRA I responsibilities. • Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. • Understanding of the drug development process. • Intermediate level of proficiency in MS Office. • Experience with EDC and CTMS strongly preferred. • Good interpersonal communication skills, good organizational skills and a great attention to detail. • Ability to complete tasks in an accurate and timely manner with minimal supervision. • Ability to discern priorities to accomplish day-to-day tasks. • Ability to manage conflicts and resolve problems effectively. • Ability and willingness to travel up to 60%.

Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) • Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) • 11 paid holidays • 15 - 25 vacation days based on years of service • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) • In-suite exercise and relaxation room • Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) • Flexible and remote work schedules