Temporary Entry Level Regulatory Affairs Jobs (NOW HIRING)

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

• Bachelor's 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 driver's 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 recruiting@lighthouselabservices.com for assistance.
Lighthouse Lab Services | 844-974-1929 | https://www.lighthouselabservices.com/

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