Clinical Research Associate (CRA) – Temporary 6 Month Contract

Clinical Research Associate (CRA) Temporary

Location: Waltham MA
Schedule: Flexible hours about 20 hours a week
Employment Type: 6 month-1 year Temporary/Contract

Pay Rate: $45/hour

Position Overview

Lighthouse Lab Services is seeking an experienced Clinical Research Associate (CRA) for a temporary opportunity in Waltham MA. The Clinical Research Associate will be responsible for monitoring clinical studies and ensuring study execution is conducted in accordance with applicable laws Good Clinical Practice (GCP) Standard Operating Procedures (SOPs) and company standards.

The CRA will serve as a primary point of contact for assigned clinical partners and investigator sites supporting study enrollment monitoring data quality protocol compliance and study close-out activities. This position will work closely with Regulatory Affairs and other members of the clinical study team to ensure studies are completed on time and to the required quality standards.

Responsibilities

• Ensure proper conduct of clinical studies in accordance with SOPs applicable laws ICH/GCP guidelines FDA regulations and company standards.
• Manage assigned operational aspects of clinical studies from study start through database lock ensuring timelines and quality deliverables are met.
• Serve as the primary point of contact for assigned clinical partners and investigator sites during study conduct.
• Facilitate communication and information flow between clinical partners investigators vendors and internal study team members.
• Attend investigator meetings either virtually or in person as required.
• Support patient enrollment and recruitment initiatives by identifying and addressing recruitment challenges with investigator sites.
• Conduct remote/electronic monitoring activities and study close-out activities as needed.
• Ensure monitoring activities are conducted in accordance with SOPs and are appropriately adjusted based on emerging study issues and technologies.
• Monitor adverse events (AEs) and serious adverse events (SAEs) working with the study team to resolve outstanding issues and ensure required information is documented.
• Maintain accurate and timely Trial Master File (TMF) documentation and study records.
• Track and submit required reports documentation updates and metrics including protocol deviations patient recruitment clinical supplies and overall study progress.
• Resolve data queries and ensure close-out activities are completed within established timelines.
• Ensure appropriate oversight of investigational products including receipt handling accountability storage conditions and destruction.
• Support database release activities as needed.
• May perform responsibilities associated with an unblinded monitor when appropriate.
• Collaborate with the Regulatory Affairs Manager and other study team members on study start-up execution and close-out activities.
• Identify and resolve protocol-related issues to support successful study execution.

Qualifications

• Bachelors degree in a life science or related field or a professional degree such as nursing pharmacy medicine or equivalent.
• Minimum of 3 years of relevant clinical research experience including site monitoring experience.
• Oncology clinical research experience preferred with approximately 2 years of oncology monitoring experience strongly preferred.
• Extensive knowledge of clinical study methodologies ICH/GCP guidelines and FDA regulations.
• Experience with clinical site monitoring study documentation and clinical trial operations.
• Strong organizational communication and problem-solving skills.
• Fluent in English.
• Valid drivers license required.

About us:

At Lighthouse Lab Services we offer solutions to help start grow and run clinical laboratories. Our recruiting team has over 21 years of proven success placing job seekers in positions ranging from entry-level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.

It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local law. Lighthouse Lab Services is committed to working and providing reasonable accommodation to individuals of all abilities including persons with disabilities.

If at any time during the application process you need an accommodation please contact for assistance.
Lighthouse Lab Services Experience:

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