Job Description
Description
Senior Clinical Research Associate, Dermatology & Rheumatology (Oregon, Nevada, Arizona,)
The senior 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.
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 The senior clinical research associate (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
The Sr CRA may also assume the following Lead CRA responsibilities:
- Reviews and approves site visit reports.
- Tracks site visit and trip report metrics and escalates issues to project teams.
- Recommends potential solutions to identified issues and work with the project managers to find resolution.
- Supports the development of annotated site visit reports, clinical monitoring plans, and monitoring tools.
- Supports the preparation and development of materials related to the training of CRAs.
- Mentors CRAs.
- Conducts on-site quality control visits with CRAs.
Requirements Education - B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience
Experience
- At least 5 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. Recruitment process: what to expect - As part of the recruitment process for this position you will meet various team members at Indero
- The first interview will be conducted by Teams (30 minutes) and the second via video conference (1 hour)
About Indero A Global Clinical Leader In
Dermatology! 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 - which includes everything from protocol design and patient recruitment to trial monitoring and biometrics - 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. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in United States.
Job Tags
Full time, Contract work, Work at office, Remote work