Clinical Research Associate II
Clinical Research Associate II
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Job Description
Job Title: Clinical Research Associate II (NV OR AZ)
Job Location: Phoenix AZ USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level:
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) ICHGCP 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 midsized CRO where your contributions are noticed and valued
The clinical research associate (CRA):
- Conducts site qualification initiation monitoring and closeout 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 followup 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 onsite 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
- 25 years experience in conducting onsite 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 problemsolving 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
At Innovaderm you will work with brilliant and driven colleagues. Our values are collaboration innovation reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
As a Clinical Research Associate you will be eligible for the following perks:
- Permanent fulltime position
- Benefits
- 401K
- Ongoing learning and development
- This position is homebased with local or regional travel required to clinical research sites
- The employee is expected to maintain a suitable dedicated home office or work space and be located near a major travel hub
Innovaderm is a contract research organization (CRO) specialized in dermatology. 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 Innovaderm continues to grow and expand in North America and Europe.
Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities upon request.
Innovaderm only accepts applicants who can legally work in the United States.
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Employment Type
Full Time
