Lead Clinical Research Associate - Contract position

ProTrials Research, Inc.; Oregon (WI); Hybrid; USD 110,000 - 170,000; Full time

Job summary

ProTrials Research, Inc. is seeking a Contract Lead Clinical Research Associate (LCRA) to lead the CRA team across studies, ensuring timely initiation, enrollment, conduct, and completion. The LCRA provides project management support, ensures adequate monitoring resources, and identifies quality issues for action plans.

The role involves directing site oversight, maintaining SOP/compliance, and guiding CRAs, CTAs, and CROs in monitoring, audits, and document control, with travel as required.

Qualifications

• Strong communication, organization, prioritization, presentation, discretion and accuracy are required.
• Previous CRA experience is preferred.
• Solutions-oriented approach to problem solving is essential.
• Familiarity with medical/pharmaceutical industry terminology and practices is expected.
• Extensive knowledge of FDA regulations and their practical implementation.
• Willingness to travel and perform remote and on-site monitoring as needed.

Responsibilities

• Provide study oversight as the primary liaison between CRAs, staff, investigators, coordinators, client personnel, and vendors.
• Ensure CRA monitoring activities comply with SOPs, regulations, and study requirements.
• Develop and manage clinical plans, timelines, and monitoring intervals; review reports and data for discrepancies.
• Create annotated visit report templates and site management documents.
• Support training and development of team members and maintain training documentation.
• Guide CRAs, CTAs, and CROs on monitoring, co-monitoring, and audits; review site visit reports.
• Oversee TMF/eTMF filing and quality control.
• Track safety events, protocol deviations, enrollment, and investigational supplies.
• Conduct qualification, initiation, interim, and close-out visits and prepare visit reports.

Skills

Communication

Organization

Prior CRA experience

Problem solving

Attention to detail

Discretion

Education

RN or Bachelor or advanced degree in biological sciences

Job description

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.

Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health.

We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.

ABOUT THE JOB

ProTrials is seeking a Contract Lead Clinical Research Associate to join our team.

The Contract 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 Contract LCRA ensures accurate and timely initiation, enrollment, conduct, completion, and provides project management support. The Contract LCRA ensures adequate study monitoring resources are in place for the study. The Contract LCRA also identifies quality issues related to clinical monitoring activities, and along with the study team, establishes action plans to address them.

HERE IS WHAT YOU WILL DO:

• 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 (SOP), 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 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

HERE IS WHAT YOU BRING TO THE TABLE:

• RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training
• Previous CRA experience preferred
• Proven excellence in professional skills including communication, organization, prioritization, presentation, discretion, and accuracy
• Solutions-oriented approach to problem solving
• Familiarity with 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