Freelance, Senior Clinical Research Associate or CRA II, Florida, USA

Job Description

Qualifications

• •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
• •B.Sc
• •in a field relevant to clinical research, nursing degree and/or equivalent experience
• •3 years of experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry
• •At least 1 year of experience in dermatology
• •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

Benefits

Responsibilities

• •The Contractual Clinical Research Associate (cCRA) 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
• •Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Indero 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