SMA I

Icon • Remote, OR

399d

About The Position

The In-house Clinical Research Associate (CRA) plays a crucial role in supporting Clinical Research Associates by providing centralized assistance in managing clinical trials. This position involves remote site management, monitoring activities, and ensuring compliance with regulatory standards. The In-house CRA will facilitate communication between study teams and investigational sites, ensuring that all necessary information is accurately conveyed and documented.

Requirements

• BA/BS preferably in the Life Sciences, or RN.
• Minimum of 2-3 years of clinical research experience as Sponsor CTS/CTA or Site Coordinator.
• Excellent understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant local regulatory requirements.
• Strong knowledge of concepts of clinical research and drug development.
• Strong working knowledge of EDC, IVRS, and CTMS systems.
• Proficient in the use of Microsoft Office.
• Ability to work highly independently across multiple studies, projects, and sites.
• Ability to work effectively in a team/matrix environment.
• Ability to understand technical, scientific, and medical information.
• Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills.
• Works with high quality and compliance mindset.
• Possess a valid driver's license.
• Must be willing to travel.

Responsibilities

• Perform remote site management and monitoring activities on assigned project(s) in accordance with FDA/EMA and/or local regulations and guidelines, ICH GCPs.
• Review study data from various sources remotely.
• Contact study sites to collect study documentation, resolve issues, and request outstanding information.
• Provide general support to the CRAs to manage investigational sites and ensure protocol and regulatory compliance.
• Remotely review EDC and drug accountability log (when possible).
• Ensure study systems are updated per agreed study conventions (e.g. CTMS).
• Assist local SSU specialist with contracts negotiations and RGL's site documentation.
• Perform QC of the eTMF (country/site level) for a certain study.
• Assist investigational sites with study start-up activities to ensure study specific supplies are received.
• Assist with the development of training content (monitoring visit training materials, monitoring visit reports, etc.) as needed.
• Contact Clinical sites for specific requests between visits, including enrollment updates, challenges with recruitment, supplies, missing TMF documentation, data entry timelines, data query follow-up, and follow-up on action items from previous site visits.
• Track patient enrollment and assist with recruitment efforts by maintaining regular site contact.
• Assist CRAs with preparation and follow-up for all types of site visits, including communicating data entry, queries, tracking reports, TMF support and maintenance, site performance, and point of escalation.
• Serve as primary CRA back-up for the site.
• May assist with tracking project specific training for site personnel.
• Conduct Pre-Study visits and/or Close-out Visits as needed; independently as approved.
• Co-monitor on assigned studies as needed.
• Assist with site quality management activities, including site audits and site inspections.
• Assist the CRA with Action Item and Protocol Deviation review and follow-up.
• Maintain FAQ list for assigned studies, as needed.
• Document site and sponsor contact and study interactions in a timely and professional manner.
• Assist with resolution of investigational site data queries, especially during interim activities and DB Lock.
• May provide study-specific direction, training, and mentoring to the monitoring team members.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree