Assistant CRA

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

📋 Description

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

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

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

• Carry out study and site management functions detailed in the task matrix.

• Complete and document training specific to the study and its associated systems.

• Provide internal support during pre-study evaluations and waiver assessments.

• Tailor site ICFs with the necessary site contact information when required.

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

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

• Review materials intended for patients and their translations.

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

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

• Follow up on absent vendor data, including ECGs, lab specimens, and e-diaries.

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

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

• Conduct trial reconciliation activities concerning CRF and query statuses, deviations, SAEs, and safety reports.

• Verify the status of document collections and initiate actions for missing, incomplete, or expired documents and open findings.

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

• Execute administrative responsibilities such as expense reports and timesheets.

• May engage in limited site contact activities during the study's initiation, management, recruitment, and close-out stages.

⛳️ Requirements

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

• Consideration may be given for equivalency achieved through a combination of suitable education, training, and/or directly related experience.

• Prior experience that provides the knowledge, skills, and abilities to perform the role, equivalent to 0 to 2 years.

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

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

• Proficient oral and written communication skills.

• Strong interpersonal and customer service abilities.

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

• Demonstrated ability to manage multiple tasks efficiently and effectively.

• Flexibility and adaptability are essential.

• Capability to work collaboratively in a team or independently.

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

• Strong computer skills and familiarity with MS Office; ability to learn and utilize relevant software.

• Proficient in extracting relevant information from study documents, electronic study data systems, CTMS, and dashboards.

• Excellent command of English and German language and grammar skills.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Home office environment.

• Occasional travel to clinics/hospitals may be necessary.

• Opportunity to collaborate with a global team at the forefront of clinical research innovation.

• Career advancement possibilities into CRA roles (promotional opportunities may require frequent travel).