Senior Clinical Research Associate Specialist
1 week ago
About the RoleThe Clinical Research Associate (CRA) is a key member of our team, responsible for monitoring clinical studies at investigative sites or remotely. The successful candidate will ensure that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Responsibilities:
- Conduct site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm SOPs, ICH/CGP guidelines, and applicable regulations.
- Participate in investigators' meetings and prepare site visit reports and follow-up letters to the investigator.
- Build productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets.
- Perform source data verification, ensure on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate.
About Us
We are Lifelancer, a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talented professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. As a CRA, you will be part of our growing team and contribute to delivering high-quality services to our clients.
What You'll Need
To succeed in this role, you should have:
- A B.Sc. in a field relevant to clinical research or a nursing degree, and/or equivalent experience.
- 2-5 years of experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry.
- Experience in dermatology is an asset.
- 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.
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