Assistant CRA – FSP

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

📋 Description

• Execute remote tasks on designated projects in collaboration with the CRA and the Clinical Lead of the study.

• Assist in site readiness and offer logistical support to the monitoring process.

• Aid with site management and remote monitoring responsibilities in alignment with SOPs and regulatory standards.

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

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

• Offer in-house assistance during pre-study evaluations and assessment waivers.

• Tailor site ICFs with relevant site contact information as required.

• Conduct remote assessments of EMR/EHR checklists.

• Confirm document collection and RCR submission status; update site EDL and site data.

• Review materials directed at patients and their translations.

• Assist site personnel with vendor qualification processes.

• Manage system access requests, grants, and revocations for site staff.

• Follow up on training for site personnel.

• Organize logistics for IM attendance.

• Maintain vendor tracking documents.

• Oversee study/site supply management.

• Support in the gathering, reviewing, and updating of essential documents.

• Track missing vendor data such as ECGs, lab samples, and e-diaries.

• Aid in the ongoing remote assessment of centralized monitoring tools.

• Assist with site payment workflows, system updates, reconciliations, and invoice follow-ups.

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

• Verify the status of document collection and initiate actions on missing, incomplete, expired, or outstanding documents.

• Perform other designated site management tasks and client-requested FSP role-profile activities.

• Complete administrative responsibilities, including managing expense reports and timesheets.

⛳️ Requirements

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

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

• An equivalent combination of relevant education, training, and/or directly related experience may also be considered.

• Basic understanding of medical/therapeutic areas and familiarity with medical terminology.

• Proficient knowledge of ICH GCP, applicable regulations, and company procedural documents.

• Strong oral and written communication skills.

• Excellent interpersonal abilities and customer service orientation.

• Good organizational and time management capabilities with a keen attention to detail.

• Ability to efficiently and effectively manage multiple tasks.

• Flexibility and adaptability to changing situations.

• Capability to work autonomously or as part of a team.

• Critical thinking, root cause analysis, and effective problem-solving skills.

• Proficient computer abilities and solid knowledge of MS Office.

• Willingness to learn and utilize relevant software and modern technology.

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

• Excellent command of the English language and grammar.

• Previous experience in oncology clinical trials is highly preferred.

🏝️ Benefits

• Fully remote working arrangement.

• Standard work schedule from Monday to Friday.

• Flexible work environment, whether in-office or home office.

• Occasional travel to clinics/hospitals may be necessary.

• Potential for promotional opportunities within the CRA career track.