Assistant Clinical Research Associate (Remote)

About the role

The company has supported the top 50 pharmaceutical companies and more than 750 biotechs across 2,700 clinical trials in over 100 countries. As an Assistant Clinical Research Associate, you perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead, supporting site preparedness, logistical support to monitoring and assigned site management and remote monitoring tasks in line with SOPs and regulatory guidelines. Limited site contact may occur during study start-up, site management, recruitment and close-out.

Key responsibilities

• Complete study and site management activities from the task matrix and complete and document study-specific training.
• Support pre-study assessments and waivers, customise the site ICF with site contact details, and verify document collection and RCR submission status.
• Review patient-facing materials and translations, and support vendor qualification, system access and vendor tracker maintenance.
• Coordinate study/site supply management, essential document collection, and follow up on missing vendor data such as ECGs, lab samples and e-diaries.
• Support site payments, system updates and reconciliations, and follow up on site invoices.
• Perform reconciliation tasks on assigned trials, including CRF and query status, deviations, SAEs and safety reports.
• Handle administrative tasks such as expense reports and timesheets.

Required profile

• Bachelor's degree in a life science discipline or related field, or a Registered Nursing certification or equivalent, with relevant formal academic or vocational qualification.
• Previous experience comparable to 0 to 2 years; equivalency through education, training and/or related experience may be accepted.
• Excellent English language and grammar skills.

Required skills

• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain knowledge of ICH GCP, applicable regulations and company procedures.
• Proficiency with MS Office and ability to learn and use other software.
• Good organisational and time management skills, attention to detail, critical thinking and teamwork.