CRO-Senior Clinical Trials Assistant

Company: Lotus Clinical Research

Job Title: Sr. Clinical Trial Assistant (CTA) or CTA

Location: 100% Remote

Who we are: www.lotuscr.com

PURPOSE

The Senior Clinical Trials Assistant supports Clinical Operations to ensure studies are completed, on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. He/she will perform all of the duties of the Clinical Trial Assistant Role, with additional leadership and oversight roles.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed

• Demonstrated mastery of all Clinical Trial Assistant duties and responsibilities including:
• Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations. Manage clinical, regulatory and study-related essential documents such as study protocols, Informed Consent Forms, etc.
• Assist with all aspects of initial study drug release including regulatory packet review and study-drug release.
• Assist in the preparation and development of study-specific training materials.
• Participate in the planning of investigator meetings.
• Interact with sites as needed to respond to issues.
• Handle incoming and outgoing shipments, as needed.
• Monitor and track monitoring visit reports. Assist with tracking of clinical trial progress including status update reports, as required.
• Participate in the review of clinical data at the case report form, data listing, and report table levels.
• Collect enrollment updates and reports on a weekly basis.
• Assists with tracking of clinical trial progress, as assigned.
• Assist PM with set up and preparation of project meetings. May include scheduling the calls, gathering updates from the team, drafting and finalizing of agenda, sending agenda to the team, and drafting and finalizing minutes.
• File and QC trial master files.
• Ensure documents are filed/uploaded into the eTMF in a timely accurate manner.
• Review and maintain up-to-date training records for the study team.
• Document changes in study team members including updating the Study Contact Sheet.
• Complete Study Plan Checklist for study Plans as assigned.
• May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• Performs data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CROs, vendors, etc.
• Provide mentorship, onboarding, and training to other Clinical Trial Assistants as needed.
• Drafting Study Plans, such as the eTMF Plan and eSignature Plan, as assigned.
• With oversight from the Lead PM, may serve as a liaison between clients, vendors, clinical sites, and internal team to ensure project specific information and ongoing updates are proactively communicated.

SUPERVISORY RESPONSIBILITIES

Position requires extensive experience and judgment to accomplish study defined goals. May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. Provides mentorship and training to other Clinical Trial Assistants.

EDUCATION and/or EXPERIENCE

• BS/BA preferred. High school diploma/certificate or educational equivalent required.
• Must possess a thorough knowledge of applicable clinical research requirements, including GCP and ICH guidelines.
• Four years of clinical research experience preferred but not required. Mastery of the Clinical Trial Assistant role.
  • If CTA, two years of research experience
• Demonstrated organizational and coordination skills with attention to detail.
• Solid understanding of clinical drug development is preferred.

SKILLS and/or ABILITIES

• Strong Microsoft Office skills.
• Strong written and verbal communication skills.
• Effective time management and organizational skills.
• Attention to detail and accuracy in work. Strong customer service orientation.
• Ability to facilitate a teamwork philosophy with a positive attitude.