Remedy Plan Therapeutics Clinical Research Associate (In-House) Remote · Full time Company website

Apply for Clinical Research Associate (In-House)

Remedy Plan Therapeutics is a clinical-stage biotech company focused on developing NAMPT inhibitors for patients with acute leukemias and solid tumors. Our mission is to solve a decades-old medical-science puzzle: targeting NAD synthesis in cancer cells without damaging healthy cells. Our lead asset, RPT1G, is a novel, small-molecule NAMPT inhibitor designed for this purpose. Our team comprises experienced scientists, clinicians, and drug developers working together to bring hope to communities affected by these diseases. For more information on Remedy Plan, visit remedyplan.com and follow us on LinkedIn.

Summary:

The In-House Clinical Research Associate (CRA) supports the planning, coordination, and execution of clinical trials. This role ensures compliance with regulatory requirements, Good Clinical Practice (GCP), and company Standard Operating Procedures (SOPs). The In-House CRA collaborates with investigative sites and cross-functional teams to ensure high-quality study conduct and timely delivery of clinical

milestones.

Key Responsibilities:

• Provide operational support for Phase I–IV clinical trials across multiple therapeutic areas, including oncology.
• Assist with site feasibility, selection, and study start-up activities.
• Coordinate Institutional Review Board (IRB)/Ethics Committee submissions and approvals.
• Maintain and reconcile Trial Master File (TMF) documentation and essential study records.
• Support remote and risk-based monitoring activities.
• Review monitoring reports and track resolution of action items.
• Monitor study timelines, enrollment, and site performance metrics.
• Assist in safety reporting, including Serious Adverse Events (SAEs) and protocol deviations.
• Facilitate communication between study sites, vendors, CROs, and internal teams.
• Support investigator meetings and study-specific training sessions.
• Ensure compliance with ICH-GCP, FDA, and global regulatory requirements.
• Contribute to audit and inspection readiness activities.

Title and compensation are commensurate with experience.

Position Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related field.
• 1–3 years of experience in clinical research or clinical trial support.
• Experience in a pharmaceutical, biotechnology, CRO, or academic research setting preferred.
• Oncology experience is a plus

Skills and Competencies:

• Working knowledge of ICH-GCP and regulatory guidelines.
• Strong organizational and time-management skills with keen attention to detail.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office and clinical systems such as CTMS, EDC, and eTMF.
• Ability to manage multiple priorities in a fast-paced environment.
• Collaborative, proactive, and solutions-oriented mindset.

Preferred Qualifications:

• Exposure to oncology trials and familiarity with RECIST or CTCAE.
• Experience supporting global, multi-center studies.
• ACRP or SOCRA certification.
• Familiarity with risk-based monitoring methodologies.