Lead Clinical Research Associate

Bayside Solutions; California (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

Bayside Solutions is seeking a Lead Clinical Research Associate (LCRA) to lead the CRA/CTA team across studies, ensuring timely initiation, enrollment, conduct, and completion. The LCRA provides project management support and ensures adequate monitoring resources while addressing quality issues with action plans.

The role requires extensive knowledge of FDA regulations, SOPs, and GCP, as travel and remote/on-site monitoring may be required.

Qualifications

• RN, Bachelor's, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training
• 5 years of CRA experience preferred
• Willingness to travel and perform remote and on-site monitoring, if needed

Responsibilities

• Provide study oversight as the primary liaison between CRAs, internal staff, study site staff, including investigators, coordinators, client personnel, and external vendors involved in all stages of the study.
• Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with SOPs, regulations, good clinical practices, KPIs, and study-specific requirements.
• Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies.
• Create annotated visit report templates and other documents and strategies related to site management and monitoring.
• Support training and development of team members, ensure compliance with study-specific training requirements, and ensure training is appropriately documented.
• Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements
• Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control.
• Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for the assigned study and review with appropriate members of the study team.
• Perform qualification, initiation, interim, and close-out visits and provide visit reports as per monitoring guidelines as needed.

Skills

CRA Leadership

Team Training

Site Management

Vendor Management

CRO Oversight

Monitoring Plans

TMF/eTMF

GCP

FDA Regulations

Travel

Education

RN

Bachelor's degree

Advanced degree in biological sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

The Lead Clinical Research Associate (LCRA) is responsible for providing direction and leadership to the Clinical Research Associate (CRA) team and Clinical Trial Associate (CTA) assigned to studies. The LCRA ensures accurate and timely initiation, enrollment, conduct, completion, and provides project management support. The LCRA ensures adequate study monitoring resources are in place for the study. The LCRA also identifies quality issues related to clinical monitoring activities, and along with the study team, establishes action plans to address them.

Duties and Responsibilities:

• Provide study oversight as the primary liaison between CRAs, internal staff, study site staff, including investigators, coordinators, client personnel, and external vendors involved in all stages of the study.
• Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOPs), regulations, good clinical practices, key performance indicators, and study-specific requirements.
• Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies.
• Create annotated visit report templates and other documents and strategies related to site management and monitoring.
• Support training and development of team members, ensure compliance with study-specific training requirements, and ensure training is appropriately documented.
• Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements
• Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control.
• Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for the assigned study and review with appropriate members of the study team.
• Perform qualification, initiation, interim, and close-out visits and provide visit reports as per monitoring guidelines as needed.

Requirements and Qualifications:

• RN, Bachelor's, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training
• Previous CRA experience preferred
• 5 years of experience
• Proven excellence in professional skills, including communication, organization, prioritization, presentation, discretion, and accuracy
• Solutions-oriented approach to problem solving
• Familiarity with the medical and pharmaceutical industry, and related terminology and practices
• Extensive knowledge of Food and Drug Administration regulations and their practical implementation
• Willingness to travel and perform remote and on-site monitoring, if needed
• Proficiency in Microsoft Word, Excel, and PowerPoint

Desired Skills and Experience

Clinical Research, Clinical Trial Management, Study Oversight, Clinical Monitoring, CRA Leadership, Team Training and Development, Site Management, Vendor Management, CRO Oversight, Clinical Monitoring Plans, Study Timelines, CTMS, TMF/eTMF, GCP, FDA Regulations, SOP Compliance, Quality Control, Data Review, Data Discrepancy Resolution, Site Visit Reports, Monitoring Letters, Serious Adverse Event Tracking, Protocol Deviations, Informed Consent Forms, Investigational Product Accountability, Clinical Supplies, Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Close-Out Visits, Audit Support, Project Management, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Communication, Organization, Prioritization, Presentation Skills, Problem Solving