DescriptionSenior Clinical Research Associate - Dermatology & Rheumatology | US West Region (Nevada, Kansas and/or Arizona preferred)The senior clinical research associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
This role will be 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 work 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.
RequirementsEducation- 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
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)
- Experience in dermatology
Recruitment process: what to expect - As part of the recruitment process for this position you will meet various team members at Indero
- The first interview will be conducted by Teams (30 minutes) and the second via video conference (1 hour)
