Assistant CRA - West & Central US

About the role

As an Assistant Clinical Research Associate you will provide support with site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. You may be assigned limited site contact activities during study start‑up, site management, recruitment, and close‑out phases.

Responsibilities

• Complete study and site management activities as defined in the task matrix and as directed for the assigned study.
• Complete and document study‑specific training; orient and train on any study‑specific systems.
• Provide in‑house support during pre‑study assessments and with pre‑study assessment waivers, as agreed for the project.
• Support customization of Site ICF with site contact details, as needed.
• Perform remote review of EMR/EHR checklist and support collection of applicable assessments.
• Verify document collection and RCR submission status; update site EDL and verify site information.
• Review patient‑facing materials and translations, as directed.
• Support site staff with vendor‑related qualification processes, where applicable.
• Ensure system access is requested, granted, and revoked for relevant site staff during pre‑activation and throughout the study.
• Follow up on site staff training, as applicable.
• Coordinate and support logistics for IM attendance, as directed.
• Maintain vendor trackers, as directed.
• Coordinate study/site supply management during pre‑activation and throughout the study.
• Support essential document collection, review, and updating in systems, as applicable.
• Follow up on missing study vendor data such as ECGs, lab samples, and e‑diaries, as directed.
• Support ongoing remote review of centralized monitoring tools, as directed.
• Support site payment processes by coordinating with various functional departments and the site.
• Support system updates and reconciliations, and follow up on site invoices throughout the study period.
• Perform reconciliation tasks on assigned trials, including CRF and query status, deviations, SAEs, and safety reports, as applicable.
• Verify document collection status in company systems and drive action for missing, incomplete, or expired documents and open document findings, as directed.
• Perform other assigned site management tasks as directed by the CRA and per the Task Matrix.
• May perform a specific role profile for FSP opportunities according to client requests.
• Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.

Education and Experience Requirements

• Bachelor’s degree in a life‑science discipline or related field, or a Registered Nursing certification, or equivalent.
• Relevant formal academic/vocational qualification.
• 0–2 years of experience providing the knowledge, skills, and abilities to perform the job, or an equivalency of education, training, and/or directly related experience.

Knowledge, Skills and Abilities

• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations, and company procedural documents.
• Effective oral and written communication skills.
• Excellent interpersonal and customer service skills.
• Good organizational and time‑management skills with strong attention to detail; proven ability to handle multiple tasks efficiently.
• Proven flexibility and adaptability; ability to work in a team or independently as required.
• Well‑developed critical‑thinking skills, including root‑cause analysis and problem solving.
• Proficient computer skills with good knowledge of MS Office and ability to learn and use appropriate software; leverage modern technology when applicable.
• Ability to extract pertinent information from study documents, electronic study data systems, CTMS, and dashboards.
• Excellent English language and grammar skills.

Working Conditions and Environment

Work is performed most of the time in an office or home‑office environment; occasional travel to clinics/hospitals may be required. Exposure to electrical office equipment. The Assistant CRA role does not involve regular travel, however, any direct promotional opportunities in the CRA career track will require frequent travel (60‑80%).

Schedule

Standard (Mon‑Fri)