Détails du poste : Clinical Research Associate (US-based)
|Home-based, United States
The clinical research associate (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.
- The clinical research associate:
- 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.
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.
- B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience;
- Good knowledge of ICH/GCP standards and applicable regulatory requirements;
- Strong verbal and written communication skills in English;
- 2-5 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry.
- 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 an asset.
We thank you for your application and please note that only those selected for an interview will be contacted.