[Hiring] Senior Clinical Research Associate @Indero

Role Description

The Senior Clinical Research Associate (Sr 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 an experienced CRA with a demonstrated ability to work autonomously to meet quality standards and deadlines.
• Focusing on dermatology and/or rheumatology developing an expertise in these therapeutic areas is interesting to you.
• You enjoy working for a mid-sized CRO where your contributions are noticed and valued.

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.

Qualifications

• B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience.
• 5 to 8 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry.
• 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.

Benefits

• Permanent full-time position.
• Vacation, sick days, 401K, Benefits.
• Travelling position with teleworking allowance.
• Ongoing learning and development.

Company Description

Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in the US.