• Supports enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements.
• Responsible for working with the principal investigator to meet or exceed study enrollment.
• Reviews the study design and inclusion/exclusion criteria with physician and patient.
• Ensures the protection of study patients by verifying informed consent procedures and adheres to protocol requirements/compliance.
• Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review. Monitors data for missing or implausible data.
• Ensures that adequate and accurate records are maintained for inspecting.
• Creates study specific tools for source documentation when not provided by sponsor.
• Collects, completes, and enters data into study specific case report forms or electronic data capture systems.
• Generates and tracks drug shipments and supplies as needed.
• Reports and follows up on serious adverse events as necessary.
• Implements study-specific communications.
• Ensures timely adherence to protocol requirements.
• Responsible for completion of all required documentation according to site works guidelines.
• Ensures timely and accurate data completion.
• Maintains accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, drug dispensing logs, subject logs and study-related communications.
• Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations.
• Communicates all protocol-related issues to appropriate study personnel or manager.
• Attends study specific on site meetings, Investigator meetings, conference calls and monthly CRC meetings as required or asked to do so.
• Apprises principal investigator, Research Operations Director and Regional site manager of all study specific medical issues for guidance.
• Assists sponsor and US FDA audit teams.
• Reviews and responds to any monitoring and auditing findings and escalates issues defined by Regional Site Manager.
• Maintains patient confidentiality according to ethical and legal requirements.
• Assists in providing coverage for satellite clinic sites as necessary or asked to do so.
• Practice and adhere to the "Code of Conduct" philosophy and "Mission and Value Statement."

• Working knowledge of medical and research terminology.
• Bachelor's Degree in science field.
• 1+ years of experience as a Clinical Research Coordinator
• Working knowledge of federal regulations, good clinical practices (GCP).
• Ability to communicate and work effectively with a diverse team of professionals.
• Excellent organizational and prioritizing capabilities.
• Strong computer skills with demonstrated abilities using clinical trial database, electronic data capture, and MS Word or Excel.
• Excellent interpersonal skills, detailed -oriented and meticulous.
• Excellent professional writing and communication skills.
• Ability to work independently in a fast pace environment with minimal supervision at off site facilities.

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