Assistant CRA

This is a fully remote position, open to applicants in Colombia.

📋 Description

• Conduct remote tasks on assigned projects in coordination with the CRA and Clinical Lead of the study.

• Assist in preparing sites and provide logistical support for the monitoring process.

• Aid with site management and remote monitoring activities in compliance with SOPs and regulatory standards.

• Execute study and site management tasks as outlined in the task matrix.

• Complete and document training specific to the study and provide orientation/training on study-specific systems.

• Offer internal support during pre-study evaluations and waivers.

• Tailor site informed consent forms with the necessary site contact information as required.

• Conduct remote EMR/EHR checklist evaluations and assist with relevant assessments.

• Confirm document collection and RCR submission status; update the site EDL and validate site information.

• Evaluate patient-facing materials and translations.

• Facilitate vendor qualification processes, system access, site staff training, IM attendance logistics, vendor tracking, and study/site supply management.

• Assist with the collection, review, and system updates of Essential Documents.

• Follow up on outstanding vendor data, including ECGs, lab samples, and e-diaries.

• Support ongoing remote assessments of centralized monitoring tools.

• Aid in site payment processes, system updates, reconciliations, and follow-up on invoices.

• Conduct reconciliation tasks related to CRFs, query status, deviations, SAEs, and safety reports.

• Verify the status of document collection and take action on missing, incomplete, or expired documents and findings.

• Execute other site management tasks and fulfill client-requested FSP role profiles.

• Complete administrative duties, including expense reports and timesheets.

⛳️ Requirements

• A Bachelor's degree in a life science discipline or a related field, or a Registered Nursing certification or equivalent relevant formal academic/vocational qualification.

• Prior experience that provides the knowledge, skills, and abilities necessary to perform the role, typically ranging from 0–2 years.

• Equivalency through a mix of appropriate education, training, and/or directly related experience may be considered.

• Fundamental knowledge of medical/therapeutic areas and familiarity with medical terminology.

• Capability to achieve and maintain a working understanding of ICH GCP, relevant regulations, and company procedural documents.

• Strong oral and written communication skills.

• Exceptional interpersonal and customer service abilities.

• Solid organizational and time management skills, with a keen attention to detail and the ability to manage multiple tasks effectively and efficiently.

• Flexibility and adaptability in work approaches.

• Ability to collaborate within a team or work independently.

• Well-developed critical thinking, root cause analysis, and problem-solving capabilities.

• Proficient computer skills along with a good understanding of MS Office; ability to learn and utilize relevant software.

• Capacity to extract relevant information from study documents, electronic study data systems, CTMS, and dashboards.

• Excellent English language proficiency and grammar skills.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.