Clinical Trials Informed Consent Specialist
3 days ago
**Job Overview:**
We are seeking a highly skilled Informed Consent Codification Associate to join our team at Labcorp Drug Development.
The successful candidate will be responsible for performing informed consent codification across multiple client instances, ensuring accurate and timely delivery of results.
About the Role:
This is an exciting opportunity to work in a fast-paced environment with a high degree of initiative. The ideal candidate will have a strong drive for process optimization and data integrity, as well as excellent communication and interpersonal skills.
Key Responsibilities:
- Perform informed consent codification across multiple client instances.
- Ensure accurate and timely delivery of results.
- Maintain and utilize a strong knowledge of SOPS and validation work procedures/standards in relation to the System Development Life Cycle.
- Triage unacceptable errors for resolution.
- Support management of metrics.
- Assist with investigating or resolving issues of quality as directed.
- Suggest process improvements where issues are seen.
- Support Six Sigma process improvement teams.
- Reviews training materials for staff.
- Mentor and support other GSS employees in their understanding and adoption of Informed consent codification.
- Lead or assist with special projects as designated.
Requirements:
- 0-1 year of experience working in clinical trials, laboratory, or specimen management.
- Knowledge of informed consent forms essential.
- Experience writing, reviewing, or reading informed consent for clinical trials.
- Knowledge of global regulation and guidance documents in relation to informed consent information.
- Proven ability to plan, prioritize, and manage in a fast-paced environment with a high degree of initiative.
- Strong drive for process optimization and data integrity.
- Excellent communication and interpersonal skills with great attention to detail.
- Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO, or related industry.
- Problem-solving/Logic Skills.
- Strong MS/Office skills in particular with Excel and Word.
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