[Remote] Senior Clinical Research Associate, Dermatology & Rheumatology, USA

Note: The job is a remote job and is open to candidates in USA. Indero is a global clinical leader in dermatology and rheumatology, seeking a Senior Clinical Research Associate to monitor clinical studies at investigative sites. The role involves ensuring compliance with protocols and regulations while building relationships with investigators to achieve study objectives. Responsibilities • 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 • 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. Skills • B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent 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 • 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 is an asset Company Overview • Indero: Your Dual-Focus CRO for Dermatology & Rheumatology At Indero, we specialize in providing comprehensive Contract Research Organization (CRO) services for dermatology and rheumatology. It was founded in 2000, and is headquartered in Montréal, Quebec, CAN, with a workforce of 201-500 employees. Its website is Apply tot his job Apply tot his job Apply To this Job