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Indero (formerly Innovaderm) · 1 day ago

Senior Clinical Research Associate, Dermatology & Rheumatology, USA

Maine, ME

Full-time

Hybrid

Senior Level

5+ years exp

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.

MedicalPharmaceuticalProduct Research

No H1B

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

Qualification

Clinical monitoringICH/GCP standardsDermatology experienceRheumatology exposureMicrosoft OfficeVerbal communicationWritten communicationProblem-solvingAttention to detail

Required

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)

Preferred

Experience in dermatology is an asset

Company

Indero (formerly Innovaderm)

Indero: Your Dual-Focus CRO for Dermatology & Rheumatology At Indero, we specialize in providing comprehensive Contract Research Organization (CRO) services for dermatology and rheumatology.

Founded in 2000

Montréal, Quebec, CAN

201-500 employees