Senior Clinical Research Associate, Dermatology & Rheumatology, US West Region (NV,KS,AZ)
US West Region (Nevada, Kansas and/or Arizona preferred)
About the role
This role is perfect for you if:
- You are a seasoned Clinical Research Associate (CRA) who thrives in autonomous environments and consistently meets high-quality standards and deadlines.
- You bring experience in dermatology and rheumatology, and you're eager to deepen your expertise in these therapeutic areas.
- You value working within a mid-sized CRO where your contributions are visible, appreciated, and have a direct impact.
Responsibilities
The Senior Clinical Research Associate (CRA):
- Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines and applicable regulations.
- Participates in investigators’ meetings.
- Prepares site visit reports and follow-up letters to the investigator.
- Builds productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets.
- Performs source data verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate.
The Sr CRA may also assume the following Lead CRA responsibilities:
- Reviews and approves site visit reports.
- Tracks site visit and trip report metrics and escalates issues to project teams.
- Recommends potential solutions to identified issues and works with the project managers to find resolution.
- Supports the development of annotated site visit reports, clinical monitoring plans, and monitoring tools.
- Supports the preparation and development of materials related to the training of CRAs.
- Mentors CRAs.
- Conducts on-site quality control visits with CRAs.
Requirements
Education
- B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience.
Experience
- At least 5 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry.
- Rheumatology exposure.
- Experience in dermatology.
Knowledge and Skills
- Good knowledge of ICH/GCP standards and applicable regulatory requirements.
- Strong verbal and written communication skills in English.
- Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines.
- Excellent judgement and problem-solving skills.
- Travel to research sites approximately 65% of the time.
- Excellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint).
About the company
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
Indero, formerly known as Innovaderm, is a world-renowned expert and clinical research leader in dermatology with over two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes. As a dual-focus CRO for dermatology and rheumatology, Indero has 25+ years’ experience in clinical research and trial delivery. Our full-service approach includes everything from protocol design and patient recruitment to trial monitoring and biometrics, providing biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need.
With capabilities in North America, Europe, Asia Pacific, and Latin America, Indero maintains vast, continuously growing relationships with investigators and patients. We also operate a dedicated research clinic through which we design and execute our own studies, making Indero the ideal CRO partner for clinical needs at a global scale.