Assistant CRA

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

📋 Description

• Conduct remote activities for assigned projects in collaboration with the CRA and the Clinical Lead of the study.

• Assist in site readiness and the monitoring process.

• Provide support with site management and remote monitoring tasks in line with SOPs and regulatory standards.

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

• Complete and document training specific to the study and orient to study-specific systems.

• Offer in-house support during pre-study assessments and assessment waivers.

• Tailor site ICFs with contact information as necessary.

• Perform remote reviews of EMR/EHR checklists and aid in relevant assessments.

• Confirm the status of document collection and RCR submissions; update site EDL and site information.

• Evaluate patient-facing materials and their translations.

• Assist in vendor qualification, site-system access, training for site staff, logistics for IM attendance, vendor trackers, and study/site supplies.

• Facilitate the collection, review, and updating of Essential Documents within systems.

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

• Support ongoing remote reviews of centralized monitoring tools.

• Coordinate site payments, system updates, reconciliations, and follow up on site invoices.

• Carry out reconciliation tasks related to CRF and query status, deviations, SAEs, and safety reports.

• Take initiative for missing, incomplete, or expired documents and address open document findings.

• Perform other designated site management duties and fulfill client-requested FSP role profiles.

• Complete administrative responsibilities, including expense reports and timesheets.

• Occasional travel to clinics or hospitals may be necessary.

⛳️ Requirements

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

• Previous experience ranging from 0 to 2 years is preferred.

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

• Basic knowledge of medical/therapeutic areas and an understanding of medical terminology.

• Familiarity with ICH GCP, relevant regulations, and company procedural documents, or the capability to acquire and maintain this knowledge.

• Strong oral and written communication abilities.

• Exceptional interpersonal and customer service skills.

• Competent organizational and time management skills with a keen attention to detail.

• Capacity to manage multiple tasks efficiently and effectively.

• Flexibility and adaptability in approach.

• Ability to work collaboratively in a team or independently.

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

• Proficient in computer skills, with a solid understanding of MS Office.

• Capability to learn and utilize relevant software and modern technology effectively.

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

• Excellent command of the English language and grammar skills.

🏝️ Benefits

• Fully remote work environment.

• Work performed in an office or home office setting.

• Standard work schedule from Monday to Friday.

• Opportunity to collaborate with a global team.

• Potential career advancement opportunities within Clinical Research Associate roles.