Clinical Studies Specialist

Benefits

Additional Information

- Member of the clinical team responsible for conducting Phase I-IV studies according to Federal Regulations and ICH guidelines. - Support clinical team, primarily in tracking, organizing and filing Phase I-IV study documents according to Federal Regulations and ICH guidelines. - Assist Clinical Team members in handling data queries, drug inventories, study invoice payments, enrollment tracking, and record reconciliation with site documents. - Assists the CRAs with organizing and planning study investigator meetings. - Ensure documents are compliant with SOPs and regulatory requirements. - Review essential/critical documents for completeness and accuracy. - A Bachelor's degree is required. - Pharma experience or professional equivalent is required. - Strong documentation or research experience - Multiple TAs. Ability to manage clinical documents for multi-site studies. - Ability to prioritize multiple tasks and/or projects with limited supervision. - Ideal candidates will possess strong organizational capabilities and strong interpersonal skills, excellent written and verbal skills. - Candidates must have a stable work history. - Foreign MD will be considered only if candidate also has clinical research experience. All your information will be kept confidential.

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Company Intel

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