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Clinical Research Associate II Contract: North Chicago, Illinois, US
Salary: $40.00 Per Hour
Job Code: 347595
End Date: 2024-06-28
Days Left: 29 days, 3 hours left
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To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - email your updated resume at Email - ...@collabera.com or give me a call at (425) ###-####. Thank you!
Job Description: Job Roles & Responsibilities:What are the top 3-5 skills, experience, or education required for this position: - Required: Bachelor's degree in science or relevant field of study
- Required: 3-5 years of US site management & monitoring experience which must include non-interventional studies and remote monitoring/logic check experience. Note: both onsite and remote monitoring experience is required.
- Required: Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
- Strongly preferred: Migraine or Migraine/gepant study experience. Neuroscience and pain management experience is a secondary preference.
- Strongly preferred: Experience with site-specific central IRB submissions/Advarra
Job Description: - Monitors activities conducted by study sites as they relate to non-interventional studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard
- Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Provides timely, and complete monitoring reports including action items and follow-up.
- Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 4 studies by applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures (SOPs) and business processes.
- Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. Proactively manages the site and ensures action plans are put into place as needed to ensure compliance.
- Ensures audit readiness at assigned sites.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events, if applicable, by site personnel.
- Ensures safety and protection of study subjects through compliance with the study monitoring plan, SOPs, ICH Guidelines, and applicable regulations.
- Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
- Manages investigator payments as per executed contract obligations.
- Manages site-specific central IRB submissions and approval, including tracking
- Maintenance of site files within the TMF.
- Manages site-specific updates to CTMS systems
- Site feasibility: at the direction of the study management team, evaluates and recommends new/potential investigators/sites on an ongoing basis. to assist in the placement of planned studies with qualified investigators/sites.
Qualifications: - Bachelor's degree in science or relevant field of study
- 5 years of site Management and Monitoring experience, which includes a period of 2-3 years of non-interventional trial and remote/logic check monitoring experience. Note: both on-site and remote monitoring experience is required.
- Experience with Migraine or Migraine/gepant trials preferred. Neuroscience and pain management experience is a secondary preference.
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines, and applicable regulations.
- Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with deadlines.
- Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.
- Ability to address study-related clinical site issues with appropriate guidance and initiate and communicate corrective action as indicated.
- Ability to use functional expertise and exercise good judgment.
- Demonstrated business ethics and integrity.
Job Requirement - Clinical Research Associate
- CRA
- Good Clinical Practices
- GCPs
- ICH
- Monitoring
- Clinical Study
- Migraine
- gepant trials
- TMF
- CTMS
- SOPs
- site management
- Biotechnology
- Pharma
- Pharmaceuticals
Reach Out to a Recruiter - Recruiter
- Email
- Phone
- Chitrank Rastogi
- ...@collabera.com
- 425#######
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