In-House Clinical Research Associate II (IHCRA II)

The In-House Clinical Research Associate II (IHCRA II) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project.

The IHCRA II will be responsible for assisting with ensuring quality and integrity of data, and additional study related activities to support the efforts of study team members.

Summary of Responsibilities:

• Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines.
• Monitor site performance and implement action plans for sites not meeting expectations in conjunction with the CRA.
• Collaborate with project team and study sites during recruitment phase, tracking patient recruitment by contacting investigators as specified for the study.
• Assist CRAs with preparation for site visits.
• Provide oversight and management of maintenance activities.
• Perform Case Report Form review, query generation and resolution against established data review guidelines.
• Might be requested to work in a client facing environment as assigned.

Qualifications (Minimum Required):

• University or college degree (biological or life science preferred), or certification in a related allied health profession from an appropriately accredited institution.
• Basic understanding of ICH-GCP guidelines.
• Basic understanding of the clinical trial process.

Experience (Minimum Required):

• A minimum of 2 years of industry experience in a related role.
• Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP.
• Good planning, organization, time management and problem-solving skills.
• Good communication skills, oral and written.

Physical Requirements:

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

Target Pay Range: $65-72K