Clinical Trials Management Associate - II
Company: Leadstack Inc
Location: Santa Monica
Posted on: November 24, 2022
Title : Clinical Trials Management Associate
Location: Santa Monica, CA
Duration: 6+ months
- Must meet all requirements for Clinical Research Associate
position and have demonstrated proficiency in all relevant
- With limited supervision conducts site evaluations/initiations
and closeout visits in addition to routine monitoring visits, as
- Assures site compliance with the routine protocol and
regulatory requirements and quality of data.
- Assists in the setting and updating of study
- Assists in CRO or vendor selection.
- With guidance from supervisor coordinates CROs or
- Drafts and coordinates review of protocols, informed consents,
case report forms and monitoring plans.
- Assists in the review of routine data and preparation of
safety, interim, and final study reports, and resolution of data
- Participates or effectively runs meetings and conference calls
with CROs, vendors, and multi-functional teams.
- May participate in abstract presentations, oral presentations
and manuscript development.
- Interfaces with individuals in other functional areas to
address routine study issues.
- May be asked to assist in the training of Clinical Research
Associates and Clinical Project Assistants.
- Under general supervision, participates in two or more
departmental or interdepartmental strategic initiatives.
- Travel is required.
- Excellent verbal, written, interpersonal and presentation
skills are required.
- Working knowledge and experience with Word, PowerPoint and
- Working knowledge of FDA and/or EMEA Regulations, ICH
Guidelines, and GCPs governing the conduct of routine clinical
- Must be able to prioritize multiple tasks, plan proactively,
and accomplish goals using well-defined instructions and
- Ability to develop tools and processes that increase measured
efficiencies of the project.
- Must be able to anticipate obstacles and proactively develop
solutions to achieve project goals.
- Must have a general understanding of functional issues and
routine project goals from an organizational perspective.
Keywords: Leadstack Inc, Santa Monica , Clinical Trials Management Associate - II, Healthcare , Santa Monica, California
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