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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Sr. Clinical Research Associate
Posted: 09/06/2024
2024-09-06
2024-10-12
Employment Type:
Contract
Job Category: Operations and Development
Job Number: 3924
Job Description
Our client is looking to add a Sr. Clinical Research Associate to its Clinical Operations team on a contract basis.
Responsibilities:
Requirements / Qualifications:
Responsibilities:
- Conduct SDV of site data
- Review of study trip reports
- Conduct co-monitoring visits
- Perform check of previously SDV’d site data in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Ensuring quality and accuracy of previously SDV’d site data
- Establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Collaborate and liaise with study team members for project execution support as appropriate.
Requirements / Qualifications:
- Bachelor’s degree in biological science or a related field.
- Requires a minimum of three (3) years as CRA experience in the pharmaceutical/biotechnology industries, or with a Clinical Research Organizations (CROs).
- Knowledge of the pharmaceutical industry, terminology, and practices.
- Knowledge of FDA regulations and their practical implementation.
- Experience implementing an electronic documentation system, is preferable.
- Ability to manage and prioritize workload effectively.
- Strong organizational and people/time management skills.
- Self-directed with limited need for supervision, adept at working independently or with others in a dynamic work environment, that presents multiple, and at-times competing priorities.
- Proficient computer skills.
- Ability to effectively manage and problem-solve several complex studies with rigorous timelines; provides high quality work resulting from attention to detail and accuracy; successfully interacts and communicates with multiple internal and external process owners.
- Strong verbal and written communication skills.
- This role may require the incumbent to occasionally travel, which will be primarily domestic. Travel will be scheduled based upon the needs of the business.