What are the responsibilities and job description for the Clinical Trials Associate position at tech-res?

Job Title

Clinical Trials Associate

Location

Bethesda, MD 20817 US (Primary)

Category

Clinical Operations

Job Type

Full-Time

Education

Bachelor's Degree

Travel

None

Job Description

Triage incoming emails, either as HelpDesk or other centralized/group email box.
Process/track/distribute/upload designated clinical trial documents/artifacts, e.g., protocol deviations, site monitoring visit reports, essential regulatory documents (ERDs), etc. Generate/distribute Monthly/Quarterly reports regarding the documentation to internal and/or external stakeholders.
Review information in centralized databases, e.g., patient recruitment/accrual, clinical data entered as EDC. Resolve queries, provide analysis assessments, and create/distribute periodic reports to internal and external stakeholders. Participate in centralized monitoring visits (CMVs).
Provide Meeting/Webinar Support, i.e., distribute invites, track attendance, and complete/distribute meeting minutes/summaries to internal and external parties.
Adherence to strict project timelines and expectations.
Troubleshoot issues by applying existing knowledge to solve new problems.
Create and maintain study specific contact lists.
Assist with other operational activities when required, including tracking CRA visit schedules and visit statuses, and sending to internal or external stakeholders as directed.
Reviewing, tracking, and managing study/project documents and filing as appropriate.
Track progress of tasks and projects.
Assist CRAs, CSMs, and/or In-House CRAs as needed.

Job Requirements

Knowledge of applicable ICH/GCP/FDA guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO setting (i.e., In-house CRA, Study Coordinator, IRB Coordinator, and Regulatory Coordinator/Associate/Specialist).
Must have excellent time management skills.
Able to identify activities along critical paths toward a specified deliverable.
Demonstrated understanding of medical and clinical trials terminology, including general understanding of Clinical Site Monitoring, Essential Regulatory Documents, and Trial Master Files.
Able to work independently or with minimal supervision and handle multiple tasks effectively while keeping up with rapid changes of priorities without loss of efficiency.
Demonstrated understanding of sponsor-specific requirements, and Standard Operating Procedures/Project Work Instructions.
Excellent professional writing and verbal communication skills.
Must be self-motivated and have a positive attitude.
Excellent organizational and coordination skills with strong attention to detail.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.

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