[Hiring] Freelance, Senior Clinical Research Associate or CRA II @Indero

Role Description

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.

Qualifications

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

Requirements

• 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

• Stimulating work environment.
• Attractive advancement opportunities.

Company Description

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

• Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery.
• Our full-service approach provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively.
• With capabilities in North America, Europe, Asia Pacific, and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
• Indero is committed to providing equitable treatment and equal opportunity to all individuals.