Clinical Research Specialist
6 days ago
Key Responsibilities:
As a Clinical Research Specialist at Lifelancer, you will be responsible for implementing and promoting the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.
Responsibilities:
- Ensure compliance of operations with governing regulatory requirements
- Create, maintain, and assume accountability for a culture of high customer service
- Efficiency in conducting literature searches for authoring various types of reports
- Author/review various safety reports (or part of such reports) for global regulatory submissions for Fortreas clients
- Perform/review Signal detection activities
- Author/review RMP ad hoc reports, Safety Update reports, BenefitRisk Evaluation, CCDS supporting document, ACOs Addendum reports
- Perform allied activities like: Generation of line listings and summary tabulation, CFIs, CFCs
- Search literature databases for relevant information, recommend label changes, author proposed label text, and prepare supporting/justification document
- Author/review SOPs/WIs/process documents or sections as applicable
- Impart/conduct Trainings for peers and team members
About the Role:
Lifelancer is seeking motivated problem solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
Why Work with Us:
At Lifelancer, we pride ourselves on being an Equal Opportunity Employer, striving for diversity and inclusion in the workforce. We do not tolerate harassment or discrimination of any kind and make employment decisions based on the needs of our business and the qualifications of the individual.
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