Assistant CRA

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

📋 Description

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

• Facilitate site readiness and logistics for the monitoring process.

• Aid in site management and remote monitoring in accordance with SOPs and regulatory requirements.

• Engage in limited site contact activities during the study initiation, management, recruitment, and closure phases.

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

• Complete training specific to the study and familiarize yourself with study-related systems.

• Provide internal assistance for pre-study evaluations and waivers.

• Assist with the customization of site ICF, review EMR/EHR checklists, collect documents, submit RCRs, and update site information.

• Review materials intended for patients and their translations.

• Support the qualification of vendors, system access, training for site staff, IM logistics, vendor tracking, and procurement of study/site supplies.

• Aid in the collection, review, and updating of essential documents.

• Follow up on outstanding vendor data, such as ECGs, lab samples, and electronic diaries.

• Assist in the review of centralized monitoring tools.

• Manage site payment processes, including system updates, reconciliations, and follow-ups on invoices.

• Carry out trial reconciliation activities involving CRFs, queries, deviations, SAEs, and safety reports.

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

• Complete administrative duties such as preparing expense reports and timesheets.

• Occasional travel to clinics or hospitals may be necessary.

⛳️ Requirements

• A Bachelor’s degree in a life science field or a related area, or Registered Nursing certification with equivalent relevant formal academic or vocational qualifications.

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

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

• Understanding of ICH GCP, relevant regulations, and company procedural documentation.

• Strong oral and written communication abilities.

• Excellent interpersonal skills and a commitment to customer service.

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

• Flexibility and adaptability in various situations.

• Capability to work both collaboratively in a team and independently.

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

• Proficient computer skills with a solid knowledge of MS Office and the ability to learn and utilize relevant software.

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

• Exceptional English language proficiency and grammar skills.

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

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible working arrangements, including remote work options.

• Competitive salary and performance-based bonuses.

• Supportive and collaborative work environment.