Clinical Research Associate
Buckeye, AZ, United States
Job Description
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The primary responsibilities of this position include, but are not limited to, the following:
- Act as the routine liaison between study site and the project team for study related issues.
- Ensures protection of subjects, subjects\' rights and the integrity of data through monitoring of adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures and protocol compliance
- Conduct pre-qualification, initiation, routine monitoring and close-out visits in accordance with the relevant SOPs.
- Source document review and comparison to CRF data
- CRF review/retrieval and data corrections
- IMP accountability
- Maintenance of on-site investigator files
- IEC/IRB documentation
- Local laboratory documentation
- Maintenance of investigational supplies
- Reviews consent process for each subject (Informed Consent Form and source documentation)
- Verify patient eligibility
- Assess protocol compliance and deviations
- Handling of safety and efficacy issues, including, but not limited to:
- Serious adverse event reports
- Adverse event trends
- Treatment failures
- Conducts and documents onsite visits/contacts, including:
- Pre-study visits
- Initiation visits
- Routine visits
- Study completion visits
- Telephone contact
- Site visit report preparation within study specific timeframe
- Responsible for all aspects of site management as described in the study plans
- Proactively identify and resolve issues and potential site and study issues.
- Assist with regulatory and study start-up activities including contract and budget negotiations, as required.
- Ensure clinical data integrity and meet study timelines.
- Provide ongoing updates and support to project management.
- Function as a lead monitor for assigned projects, as required
- Perform Assessment and Training Visits
- Mentor junior members of the team.
- Prepare and deliver staff training sessions.
- Clinical Review of individual patient listings
- Initial clinical review of comprehensive patient data listings
- Initial review of study start-up materials: SOPs, draft CRFs, completion manual, compliance forms, study prompters/calendars
- Assist in the day to day running of projects assigned.
- Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.
- Participate in project administration as required e.g., photocopying, binder preparation, start-up pack preparation etc.
- Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice.
- Perform other duties as assigned by management
- At minimum, Bachelor\'s degree (BSc, BA, or RN equivalent) in biological or science-related field or equivalent experience
- At least 3 years\xe2\x80\x99 experience as a Clinical Research Associate with a sound track record in managing clinical trial sites
- Experience in monitoring Neurology or CNS clinical trials, Alzheimer\xe2\x80\x99s, Parkinson\xe2\x80\x99s etc
- Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
- Excellent interpersonal skills, including communication, presentation, persuasion, and influence.
- Excellent organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct, and highly effective in developing solutions to those problems
- Effective knowledge of the drug development process and the Theradex organizational structure
- Strong communication skills: verbal/written
- Proficient knowledge of Outlook, Word and Excel
- Valid Driver\xe2\x80\x99s License and Passport preferable
- Fluent in English
- 10 hour shift
- 8 hour shift
- Bachelor\'s (Preferred)
- CRA: 3 years (Required)
- Neurology: 3 years (Preferred)
- CNS clinical trials: 3 years (Preferred)
- Alzheimer or Parkinson: 3 years (Preferred)
- Night Shift (Preferred)
- Overnight Shift (Preferred)
- Day Shift (Preferred)
- 75% (Preferred)
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Job Detail
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Job IdJD4251864
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationBuckeye, AZ, United States
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EducationNot mentioned