[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 aSenior 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 bolthires Office (i.e., Word, Excel, PowerPoint)• Experience in dermatology is an assetCompany 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