Assistant CRA

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

📋 Description

• Conduct remote tasks on designated clinical research projects in coordination with the CRA and study Clinical Lead.

• Facilitate site readiness and offer logistical assistance to the monitoring process.

• Assist in site management and remote monitoring responsibilities in compliance 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 familiarize yourself with study-specific systems.

• Aid in pre-study evaluations, waivers, and the customization of site ICF.

• Carry out remote EMR/EHR checklist reviews and assist with data collection activities.

• Confirm document collection, RCR submission status, and site details.

• Review materials intended for patients and their translations.

• Assist in vendor qualification, system access, staff training, and logistics for IM attendance.

• Maintain vendor trackers and oversee study/site supply management.

• Support the collection, review, and updating of essential documents within systems.

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

• Assist in the remote review of centralized monitoring tools.

• Aid in site payment processes, system updates, reconciliations, and invoice follow-ups.

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

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

• Execute other assigned site management duties as directed by the CRA.

• Promptly complete administrative tasks such as expense reports and timesheets.

⛳️ Requirements

• Bachelor's degree in a life science field.

• Prior experience equivalent to 1–2 years.

• Consideration may be given to a combination of relevant education, training, and/or directly related experience.

• Fundamental knowledge in medical/therapeutic areas and medical terminology.

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

• Strong oral and written communication abilities.

• Exceptional interpersonal and customer service skills.

• Good organizational and time management skills, along with a keen attention to detail.

• Demonstrated ability to manage multiple tasks effectively and efficiently.

• Adaptability and flexibility.

• Ability to work collaboratively in a team or independently.

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

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

• Capacity to learn and utilize appropriate software and modern technology.

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

• Excellent command of English and Turkish, including grammar skills.

• Willingness and capability to perform remote tasks and limited site contact activities as required.

🏝️ Benefits

• Competitive salary.

• Comprehensive benefits package focused on employee health and well-being.

• Flexible work culture.

• Emphasis on work-life balance.

• Collaborative workplace environment.

• Opportunities for sharing expertise and collaborating with colleagues.

• Valued diverse experiences, backgrounds, and perspectives.