Clinical Operations Specialist - Clinical Affairs 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
- Clinical Trial Operations Management
Ability to support and manage all phases of clinical trials, including start-up, IRB submissions, enrollment, maintenance, and close-out, while ensuring compliance with protocols and timelines.
- Cross-Functional Collaboration & Stakeholder Management
Strong capability to work across internal teams, clinical sites, and vendors, serving as a key point of contact and ensuring alignment to achieve study milestones.
- Regulatory & Compliance Knowledge (ICH/GCP, FDA)
Solid understanding of regulatory requirements, including ICH/GCP guidelines and FDA standards, ensuring all clinical activities and documentation remain compliant.
- Risk Management & Problem Solving
Proactive identification of risks and development of contingency plans, with the ability to partner with leadership to resolve issues andmaintainproject progress.
- Clinical Documentation & TMF Management
Expertise in preparing, reviewing, andmaintainingessential clinical documents and Trial Master Files (TMF), ensuring accuracy, completeness, and audit readiness.
- Organization, Planning & Execution
Exceptional organizational skills with the ability to manage multiple priorities, track study progress (e.g., site activation, enrollment), and ensuretimely execution of deliverables.
Professional Experience
- Collaboratewith other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles
- Identifyrisk (positive and negative) and contingencies, and partner with project leader in problem solving and resolution efforts
- Serve as primary administrative contact for clinical sites, vendors, and trial teams. May serve as primary contact for management related activities as per project requirements
- Mange cross-collaboration of the sub-team to support milestone achievement and to manage issues and obstacles
- Support the project leader in ensuring the financial success of the project.
- Identifylessons learned and implement best practices
- Support all operational aspects of assigned clinical trial(s), including conduct of study start-up, Institutional Review Board (IRB) submissions, enrollment, study maintenance, and close-out
- Conduct study tracking activities (e.g. sites activation & participant enrollment status, reconciliation activities, filing & archiving)
- Assistthe Trial Team with the development, oversight, and/or completion of essential clinical documents including, but not limited to clinical study protocol, informed consent form, training slides and materials, presentation materials, and study documents
- Participate in the administrative review and facilitation of monitoring and data reports, including letters and correspondence to sites, queries to sites, and essential document collections
- Assistwith the oversight and maintenance of the study's TMF
- Supply communications and tracking/management
What You Bring To The Table
- Minimumrequirement of a BA/BS or equivalent degree
- Bachelor's Degree In life sciences or related field
- At least 2 years of clinical research experience
- Knowledge and understanding of ICH/GCP guidelines and FDA requirements for INDs and NDAs
- Flexibility and adaptability within a highly dynamic clinical environment
- Effective interpersonal and communication skills
- Ability to work independently as well as part of a team
- Outstanding organizational skills with the ability to multi-task and prioritize
- Ability to build and maintain successful professional relationships with vendors, other staff and investigators
- Experience with TMF maintenance and management
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