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Research Associate - Clinical Research
Develops client materials according to project requirements. Monitors project changes to ensure documentation and software conforms to new requirements.
Produces project-specific documentation, operating procedures, standards, and work flows with minimal supervision.
Supports data management activities. Works with clients and internal subject matter experts to develop software specifications. Documents specifications and obtains approvals.
Evaluates software specifications, writes, and executes test scripts to verify software meets specifications.
Processes incoming and outgoing project materials. Monitors, verifies, and tracks receipt of documentation and ensures appropriate distribution of materials to internal and external research personnel and sites.
Prepares general correspondence, agendas and meeting minutes, reports, and other project-specific documentation. Ensures review, approval, and distribution to internal staff and external project participants.
Designs, builds, and updates spreadsheets and other tracking tools.
Identifies and investigates problems and recommends and implements corrective action.
Maintains clinical research records and related documents.
Coordinates the activities of smaller, well-defined projects including coordinating data safety monitoring boards.
Reports status of activities and problems to operations and project managers as appropriate.
Complies with company policies, procedures, and standards.
Ensures work is completed on time and is of the highest quality possible.
Performs related duties as assigned.
Bachelorís degree in science, health, or related field. Masters degree preferred.
Two-Five years of relevant experience. Previous experience with a pharmaceutical company, CRO, or with NIH is desirable.
Familiarity with FDA and GCP regulations desirable.
Knowledge of Microsoft Office tools such as Word, Excel, and PowerPoint. Experience using data management systems preferred.
Excellent written and verbal communication skills.
Good analytical and problem solving skills. Detail-oriented.
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