Clinical Trial Program Lead

Jobtailor; California (MO); On-site; USD 70,000 - 110,000; Full time

Job summary

JobTailor is seeking a Clinical Research Coordinator who will support the operational aspects of clinical studies, including planning, start-up, enrollment, and close-out. You will help prepare study plans, ICFs, recruitment strategies, and monitoring plans, while maintaining documentation and vendor management.

The role requires a Life Sciences degree and 3+ years of clinical research experience, with strong knowledge of ICH/GCP and ISO standards. Proficiency in MS Office is essential.

Qualifications

• Bachelor’s degree in Life Sciences or related field as outlined in essential duties.
• 3+ years of experience in clinical research.
• Clinical monitoring experience or oversight including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits.
• Experience writing, reviewing and editing protocols.
• Knowledge of applicable quality standards (ICH/GCP, ISO 20916) and applicable local and national regulations governing clinical research.
• Proficiency in Microsoft Office programs (Word, Excel, PowerPoint, Outlook, Teams, SharePoint, MS Project).
• Authorization to work in the United States without sponsorship.

Responsibilities

• Support coordination and management of operational aspects of a study including planning, start-up, enrollment and close out activities.
• Participate in preparation, review and implementation of study plans and documents including timelines, protocols, ICFs, recruitment plans, monitoring plans, vendor plans and essential documents.
• Support planning and management of systems and materials to support clinical studies.
• Maintain tools to monitor study health, timelines, and finances to management.
• Support study database development by reviewing CRF design, UAT, and guideline development.
• Support sample management activities including planning, handling, shipping, processing, and resulted.
• Identify, select, start-up and monitor clinical research sites.
• Support site contracting and budget management including negotiations, invoice review, accruals, and budget tracking.
• Oversee site management activities: training, data entry, TMF, adherence to study plans.
• Conduct monitoring activities as needed.
• Assist in study closure including database lock, site/IRB closure, analyses, and report development.
• Support vendor oversight for clinical studies.
• Provide proactive communication to sites and cross-functional team members.
• Participate in team meetings and interact with investigators, site staff, vendors, and leaders.
• Support audits and maintain compliance with QMS policies.
• Maintain regular attendance and inclusion mindset.
• Travel up to 10% as needed; attend off-site meetings.

Skills

clinical research

clinical monitoring

data review

query resolution

protocol writing

protocol editing

case report form design

user acceptance testing

budget management

sample management

communication

coordination

teamwork

leadership

problem-solving

attention to detail

organizational skills

proactive mindset

inclusion mindset

accountability

Education

Bachelor’s Degree in Life Sciences

Tools

Microsoft Office

Job description

JobTailor is seeking a Clinical Research Coordinator who will support the operational aspects of clinical studies, including planning, start-up, enrollment, and close-out. You will help prepare study plans, ICFs, recruitment strategies, and monitoring plans, while maintaining documentation and vendor management.

The role requires a Life Sciences degree and 3+ years of clinical research experience, with strong knowledge of ICH/GCP and ISO standards. Proficiency in MS Office is essential.