Clinical Research Coordinator
Clinical Research Coordinator
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1Year
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Perform study subject visits including:
- Screening and recruiting subjects.
- Dosing and administering study drugs or implementing study methodologies.
- Accounting for study drugs.
- Communicating with subjects and medical providers including the Principal Investigator and SubInvestigators.
- Collecting labeling storing and shipping specimens.
- Entering patient and research data into designated systems.
- Maintaining patient charts and resolving research queries.
- Screening and recruiting subjects.
- Ensure adherence to Good Clinical Practice (GCP) standards.
- Monitor study activities for compliance with protocols regulations and site requirements.
- Maintain records of study activity including case report forms drug dispensation records and regulatory forms.
- Track subject enrollment and document dropout information communicating updates as directed.
- Assess eligibility of potential subjects through screenings medical record reviews and discussions with healthcare professionals.
- Oversee subject enrollment ensuring informed consent is properly obtained and documented.
- Record and report adverse events and side effects to oversight agencies as necessary.
- Prepare for and participate in quality assurance audits by study sponsors or regulatory groups.
- Create and maintain studyrelated documents such as protocol worksheets procedural manuals and progress reports.
- Evaluate proposed study protocols for factors such as data management plans and subject risks.
- Provide instruction to research staff on study standards and procedures.
- Collaborate with investigators and management to prepare reports or presentations on study results and procedures.
- Communicate with laboratories or investigators regarding findings.
- Stay updated on clinical research trends through literature review continuing education and conferences.
- Order drugs or devices needed for study completion.
- Document findings in clinical trial management systems (CTMS) and other platforms as directed.
- Travel to investigator meetings company sites or sponsorrequired meetings as needed.
- Perform additional duties as assigned including those typically handled by research assistants.
Requirements
Requirements:
- Knowledge of medical terminology and principles of administration.
- High school diploma or degree in nursing or a healthrelated field.
- At least 2 years of onthejob training as a clinical research assistant or study coordinator.
- Completion of continuing education certifications including:
- IATA (dangerous goods handling).
- GCP (Good Clinical Practice).
- BLS/Phlebotomy course (if required).
- CPR course (as arranged by the company).
- Stericycle training during the first week of employment.
- IATA (dangerous goods handling).
Physical Requirements:
- Prolonged periods of sitting at a desk and working on a computer.
- Periods of standing and walking around the office.
- Ability to lift up to 20 pounds.
- Exposure to human bodily fluids.
- Occasional night and weekend work schedules.
- Possible overtime as needed.
- Travel to sponsorrequired meetings as necessary.
- Work performed primarily in a clinical or office environment.
Employment Type
Full Time
