Clinical Research and Quality Assurance Associate

Job Description:

The Clinical Research and Quality Assurance (CRA/QA) Associate is responsible for ensuring the integrity, compliance, and quality of clinical trials and GxP operations at Rise. This dual-function role combines oversight of clinical trial activities, including monitoring, data management, and site management, with quality assurance responsibilities in manufacturing documentation, supplier qualification, and material control. The ideal candidate has a strong understanding of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards and thrives in a dynamic, cross-functional environment.

Key Responsibilities

Clinical Research Responsibilities

• Monitoring:
  Oversee and monitor clinical trials to ensure they are conducted, recorded, and reported according to the study protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
• Site Management:
  Identify, evaluate, and initiate clinical trial sites, including conducting Pre-Study Site Visits (PSSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV). Provide training to site staff as needed.
• Data Management:
  Verify source data accuracy and perform ongoing data review and query management. Generate and distribute periodic query reports to ensure data compliance and timeliness.
• Regulatory Compliance:
  Ensure the safety and rights of study participants are protected. Assist with the preparation and review of regulatory submissions, safety reports, data listings, and statistical summaries.
• Cross-Functional Coordination:
  Collaborate with internal clinical, regulatory, and manufacturing teams to ensure alignment across project timelines, documentation, and quality standards.

Quality Assurance Responsibilities

• Raw Material and Batch Record Review:
  Review and disposition quarantined raw materials. Issue, review, and approve manufacturing batch records and associated documentation to ensure compliance with GMP and internal procedures.
• Labeling Control:
  Generate label proofs and final labels for products manufactured at Rise, ensuring accuracy, traceability, and compliance with labeling standards.
• Supplier Qualification:
  Conduct quality assessments and audits to evaluate supplier suitability for providing materials and services in accordance with Rise’s quality requirements.
• Document Control and Archival:
  Scan, review, and upload documentation to support the archival of records related to GxP operations. Maintain accurate and retrievable quality and clinical documentation in accordance with company procedures.
• Continuous Improvement:
  Contribute to the development, review, and implementation of quality systems, CAPAs, and process improvements to support operational excellence.

Qualifications

• Bachelor’s degree in life sciences or related discipline (advanced degree preferred).
• Minimum of 3–5 years of experience in clinical research and/or quality assurance within a GxP-regulated environment.
• Thorough understanding of ICH-GCP, FDA, and GMP regulatory requirements.
• Strong organizational skills with attention to detail and ability to manage multiple priorities.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite and electronic data capture (EDC) or quality management systems.

Preferred Skills

• Experience working in both clinical and manufacturing environments.
• Familiarity with regulatory inspections and audit readiness activities.
• Ability to work collaboratively across departments and independently with minimal supervision.
• Knowledge of biologics or live biotherapeutic product development is a plus.

What We Offer:

· Competitive salary and benefits package.

· Hands-on experience with advanced therapeutic technologies.

· Opportunity to contribute to groundbreaking therapies in a collaborative, science-driven company.

Job Type: Contract

Benefits:

· 401(k) matching

· Dental insurance

· Health insurance

· Health savings account

· Vision insurance

Work Location: In person

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About Rise Therapeutics

Rise Therapeutics is an emerging, privately held company located in Rockville, Maryland , which leverages its expertise in synthetic biology and immunological drug development to create novel cellular-based immune therapies. With a strong emphasis on product development and its internal clinical GMP manufacturing infrastructure, Rise is focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. Our drug development focus is driven by new microbiome-related discoveries enabling development of targeted, first-in-class immune modulatory drugs for the treatment of inflammation, autoimmunity, cancer, and infection. In the context of its expertise in synthetic biology medicine, proprietary TPX oral drug delivery platform, and clinical GMP manufacturing capabilities, Rise is creating and rapidly advancing life changing cellular-based medicines to the market. For more information, go to www.risetherapeutics.com.