Clinical Research Associate II - Dermatology & Rheumatology

1w1 week ago

Innovaderm Research Inc.

Portland, US · Full-time · $95,000 – $125,000

About this role

The Clinical Research Associate II (CRA II) monitors the progress of clinical studies at investigative sites or remotely. They ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH-GCP, and applicable regulatory requirements. This role suits experienced CRAs eager to develop dermatology expertise.

Daily tasks include conducting site qualification, initiation, monitoring, and close-out visits per the monitoring plan and guidelines. CRAs participate in investigators’ meetings, prepare visit reports, and build relationships with site staff to meet recruitment targets. They verify source data and manage study drug accountability.

At Indero, formerly Innovaderm, work alongside brilliant, driven colleagues in a mid-sized CRO where contributions are valued. The environment emphasizes collaboration, innovation, reliability, and responsiveness. Indero is a global clinical leader in dermatology with over two decades of experience.

Advance in a stimulating setting with attractive opportunities in dermatology trials across indications and patient populations. Travel to sites approximately 65% of the time supports hands-on monitoring. Join a team focused on quality standards and deadlines in this specialized therapeutic area.

Requirements

B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience
2-5 years experience as CRA conducting on-site clinical monitoring in biotechnology, pharmaceutical, and/or CRO industry
Good knowledge of ICH/GCP standards and applicable regulatory requirements
Strong verbal and written communication skills in English
Ability to prioritize 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 (Word, Excel, PowerPoint)

Responsibilities

Conducts site qualification, initiation, monitoring, and close-out visits according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/GCP 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 and ensures on-site study drug storage, dispensing, accountability, data collection, and regulatory document collection is adequate

Benefits

Work with brilliant and driven colleagues
Stimulating work environment emphasizing collaboration, innovation, reliability and responsiveness
Attractive advancement opportunities
Global clinical leader in dermatology with broad experience across indications and patient populations