Job Description
Description
- 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."
Requirements
Primary responsibility is to screen, enroll and follow study subjects ensuring protocol compliance and close monitoring while the subjects are on study. Responsible for all data collection, source documentation, completing study specific case report forms, and submission of adverse experience reports.
- Working knowledge of medical and research terminology.
- 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.
Medix
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