Clinical Research Associate II

January 15

⛰️ Colorado – Remote

Although this job is listed in Colorado, this company may be open to hiring remote in other states.

💵 $66k - $80k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

🦅 H1B Visa Sponsor

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CPC

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CPC is a trusted tech partner that specializes in IT support and IT services, providing a wide range of solutions including sales and maintenance of new, used, and factory recertified computer hardware and software. Established in 1962, CPC leverages a deep bench of engineers and consultants to offer innovative and efficient IT solutions tailored to both businesses with or without internal IT departments. With a focus on value, innovation, reputation, and excellence, CPC supports various industries including remote work, healthcare, and manufacturing, ensuring businesses stay up, running, and protected. The company partners with leading tech brands such as Citrix, IGEL, LG, Nutanix, Arctic Wolf, NoMachine, Zebra Technologies, and DELL, and offers both new and refurbished equipment. CPC is committed to enhancing business operations through effective IT solutions and services.

IGEL Technology • Thin Client • Dell • HP • Lexmark

51 - 200 employees

🔧 Hardware

☁️ SaaS

📋 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 the following monitoring visits: Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, 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