Senior Clinical Research Associate

Molecular Insight Pharmaceuticals

Experience: 4+ yrs
Location: United States
Job type: Full-time

Required skills

GCP
ICH Guidelines
TMF
ISF
CRF
Regulatory Submissions

About the role

Senior Clinical Research Associate (Sr. CRA) 5.4.26.docx

Why Join iMDx

At Insight Molecular Diagnostics (iMDx), our mission is to democratize access to molecular diagnostic testing. At our heart, we are a science-driven organization focused on giving clinicians and researchers the diagnostic tools they need to help improve patient outcomes.

Join us and be part of a team that’s redefining what’s possible in healthcare.

Core Competencies

Site Management & Monitoring Excellence
Expertise in managing andmonitoringclinical trial sites, including conductingselection, initiation, monitoring, and close-out visits while ensuring compliance with protocols and regulatory requirements.

Regulatory Compliance & GCP/ICH Expertise
Strong knowledge and application of clinical research regulations, ensuring adherence to GCP, ICH guidelines, and sponsor expectations tomaintaindata integrity and audit readiness.

Clinical Trial Execution & Oversight
Ability to track and manage study progress, including enrollment, regulatory submissions, CRF completion, and data query resolution to ensure successful study delivery.

Stakeholder Communication & Training
Skilled in delivering protocol training,maintainingclear communication with site personnel, and collaborating with cross-functional teams to drive alignment and resolve issues.

Risk Assessment & Problem Solving
Proactively assesses site performance,identifiesrisks or compliance gaps, and escalates issues appropriately while drivingtimelyresolution.

Organization, Planning & Results Orientation
Strong ability to manage multiple priorities, plan effectively, andmaintainhigh attention to detail while delivering results within timelines and quality expectations.

Professional Experience

Monitor and manage clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations, contributing to high-quality clinical data
Conduct all site visits (selection, initiation, monitoring, and close-out) in alignment with GCP and ICH guidelines
Collaborate with site staff to implement and track recruitment strategies aligned with study timelines and enrollment goals
Deliver protocol and study-specific training to site personnel,maintainingclear and consistent communication to manage expectations and resolve issues
Evaluate site performance and protocol adherence, escalating quality concerns to ensure compliance and data integrity
Track study progress, including regulatory submissions, subject enrollment, CRF completion, and data query resolution
Ensure essential documents are collected,maintained, and audit-ready within the TMF and ISF per regulatory standards
Document site activities, visit findings, and follow-up actions through detailed reports and correspondence
Partner with cross-functional teams to support study execution and ensure alignment with project objectives
Support recruitment planning and site financial activities, including investigator payments and site budget processes

What You Bring To The Table

Bachelor’s degree in life sciences or a related field;Master’sdegree preferred
CCRP, CCRA, or ACRP certification preferred
Minimum of 4 years of clinical trial management experience
Intermediate knowledge of clinical trial processes, including planning, design, conduct, and execution
Strong understanding and application of clinical research regulatory requirements
Broad protocol knowledge with foundational therapeutic area understanding
Excellent written and verbal communication skills, including strong presentation abilities
Strong problem-solving and critical thinking skills
Effective planning, time management, and prioritization abilities
Ability to organize resources, set clearobjectives, and provide direction to achieve goals
Proven ability to manage changing priorities and adapt to evolving circumstances

Physical Demands

Standing, sitting, walking, bending, reaching, manual manipulation, and lifting 25 pounds.
Ability to have full-body movement
Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for at least 50% of a typical working day.
Ability to travel 15% domestically and internationally if required.

Job Scope, Additional Duties, and Employment Status:

This job description is intended to provide a general overview of the position and does not include all duties, responsibilities, or tasks that may be assigned. The scope of this role may change at any time based on organizational needs, business priorities, or operational requirements. Employees may be required to perform additional duties outside of the general scope of this position as assigned.

Employment with the Company is on an at-will basis, meaning either the employee or the Company may terminate the employment relationship at any time, with or without cause or notice, subject to applicable law.

Probationary Period:

Employment is subject to an initial 90-day probationary period, during which performance, conduct, and overall role fit will be evaluated. Continued employment beyond this period is contingent upon satisfactory performance and alignment with organizational expectations.

Why Wait? Apply Today!

At iMDx, every role has a purpose, and every team member plays a part in changing lives. Your skills, ideas, and passion could help shape the future of precision medicine—making life-changing healthcare accessible to people everywhere.

If you’re ready to do work that truly matters, we’d love to hear your story. Join a team of innovators, problem-solvers, and collaborators who turn complex science into clarity and impact.

This is your moment. Don’t wait—apply now and be part of something extraordinary. Together, we can create the future of healthcare.

About Molecular Insight Pharmaceuticals

Develops molecular diagnostic tests for transplant rejection and oncology.

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