B.Sc. in a relevant field or nursing degree with equivalent experience
5-8 years of on-site clinical monitoring experience in biotech, pharma, or CRO
Strong knowledge of ICH/GCP standards and regulatory requirements
Excellent verbal and written communication skills in English
Proficient in Microsoft Office (Word, Excel, PowerPoint)
Ability to prioritize tasks and work under pressure
Experience in dermatology is a plus
Responsibilities
Conduct site qualification, initiation, monitoring, and close-out visits according to the monitoring plan
Participate in investigators' meetings
Prepare site visit reports and follow-up letters to investigators
Build productive relationships with investigators and site staff to achieve study objectives
Perform source data verification and ensure adequate study drug storage and accountability
Benefits
Permanent full-time position
Vacation and sick days
401K and additional benefits
Traveling position with teleworking allowance
Ongoing learning and development opportunities
Full Job Description
Description
Senior Clinical Research Associate, dermatology and rheumatology CRO, Northwest regions of the United States
The Senior Clinical Research Associate (Sr 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.
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/or rheumatology developing an expertise in these therapeutic areas is interesting to you
You enjoy working for a mid-sized CRO where your contributions are noticed and valued
RESPONSIBILITIES
The Senior clinical research associate (Sr CRA):
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
Requirements
Education
B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience
Experience
5 to 8 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry
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)
Experience in dermatology is an asset
Our company
The work environment
At Indero, 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.
In this position, you will be eligible for the following perks:
Permanent full-time position
Vacation, sick days, 401K, Benefits
Travelling position with teleworking allowance
Ongoing learning and development
Work location
This position is opened to candidates across the USA specifically Western United States (home-based position).
