Freelance Clinical Research Associate

Contractual CRA with experience in Dermatology and/or Rheumatology
The Contractual Clinical Research Associate (cCRA) 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 developing an expertise in this therapeutic area 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, Indero 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

Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training

Education

B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience

Experience

3 years of experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry

At least 1 year of experience in dermatology

Knowledge and skills

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)

Benefits

Permanent full-time position

Company benefits package

Ongoing learning and development

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 Canada.

#J-18808-Ljbffr