USA – Clinical Research Associate in Chicago, IL

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USA - Clinical Research Associate - LanceSoft - Chicago, IL - work from home job
Company: LanceSoft
Job description: Job Description
What are the top items on resumes you want me to look for before I send them to you for consideration? Year of experience as CRA (ideally 4-5 years), has done monitoring at more than one company/CRO (at least different 2 is preferred), SOCRA, ACRP or equivalent certification preferred. Additional info: Pro-active and collaborative (we need someone who has a take-charge attitude). Probably not obvious on a resume, but we would like to have someone who has worked on a study from start to finish = set-up monitoring plan, conducted site monitoring, and conducted site close-out.

This CRA role will require international travel (Italy), % no more than 25%.

Clinical Research Associate

JOB DESCRIPTION/POSITION SUMMARY: The Clinical Research Associate is primarily responsible for carrying out the responsibilities involved in the execution of clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various phases in the life cycle of the product.

Responsibilities
Monitor activities conducted by clinical investigative sites as they relate to sponsor clinical studies to ensure successful execution of the protocol.
Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Protocol/Amendment(s), Monitoring Plans, and to quality standards in conducting clinical research.
Ensure subject safety and verify diligence in protecting the confidentiality and well-being of study subjects
Conduct site qualification, site initiation, interim monitoring and close out visits for Phase 1-4 studies
Verify completeness, accuracy, consistency, and compliance/quality of trial data collected at study sites; identify deficiencies and discrepancies and provides remedial training and/or corrective action as required; generate and resolve queries in between monitoring visits
Complete monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended action to secure compliance
Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

Qualifications
MINIMUM REQUIREMENTS: Education and Experience (in years):
BA or BS with scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent. Minimum of 4 years of clinical research monitoring experience.
4+ years of clinical research monitoring experience. Experience in on-site or remote monitoring of investigational drug or device trials is required.
Industry certification - SOCRA or ACRP, or equivalent preferred.
Read, write and speak fluent English

Knowledge and skills:
This role may be office and/or home-based. Infrequent visits to a Company office may be requested
Ability to travel preferred but flexible, maximum 25%
Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable federal regulations.
Experience in monitoring sites, ability to prioritize and multi-task in a fast-paced environment
Detailed oriented, with strong time management and organizational skills
Excellent communication and team skills
Effective interpersonal skills
Working knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc.
Demonstrated business ethics and integrity. USA - Clinical Research Associate - LanceSoft - Chicago, IL - work from home job
Expected salary: $45 - 50 per hour
Location: Chicago, IL USA - Clinical Research Associate - LanceSoft - Chicago, IL - work from home job
Job date: Fri, 25 Aug 2023 06:05:07 GMT
Apply for the job now! USA - Clinical Research Associate - LanceSoft - Chicago, IL - work from home job      

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