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Clinical Researcher / Coordinator
Skills
Job Description
Job purpose / summary
This role may suit someone from a science background or someone currently working within a primary care role where their duties might include monitoring vital signs, phlebotomy, clinical area preparation, etc. This role also includes general operational support and administrative duties related to clinical activities supporting research studies. This role will support the development of projects and processes from study initiation through completion by collaborating with investigators and other stakeholders.
Duties and responsibilities
The ideal candidate will be responsible for:
- Maintaining accurate and complete procedural documentation including study participant and site-level documentation in compliance with institutional, local, provincial, and federal guidelines and regulations related to clinical research
- Maintaining detailed documentation of the research study including but not limited to individual patient files
- Ensuring proper storage of essential study documentation including personal health information per institutional and regulatory requirements, including study audits
- Creating source documents and any other research documents required for the successful conduct of a clinical research study
- Facilitating and coordinating protocol related research procedures, study visits, and follow up
- Providing regular and consistent updates to the research team regarding screening and enrollment activities, including internal staff and external clients
- Creating all patient research visits and procedures consistent with protocol requirements
- Collecting Laboratory, Pathology, Oncology, Treatment and Outcome data necessary to complete Case Report Forms as required
- Discussing study medication, required procedures, eligibility criteria, and impact on office flow with investigators and staff
- Attending investigator meetings, site initiation visits, and coordinator meetings to obtain training on drug preparation and administration and general knowledge about a protocol with a focus on clinical procedures
- Ensuring essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements
- Preparing study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision
Competencies
The ideal candidate will demonstrate competencies in the following areas:
- Maintaining a high level of knowledge and understanding of assigned protocols, including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information, and drug accountability requirements
- Supporting patient management, regulatory maintenance, data entry services, and clinical research training and education
- Providing subject care and data collection procedures in adherence with the assigned study protocol and accordance with good clinical research principals
- Research Management
- Time Management
- Information Management
- Data Management
- Good Clinical Practice
- Good Laboratory Practice
- Medical Research
- Research & Development
- Research Administration
- Case Management
- Clinical Support
- Procedure Development
- Future Studies
Tools and technologies
- Web-based Software
- Embedded Services
- Microsoft Office
- Microsoft Access
- Microsoft Windows
- Microsoft Suite
- Microsoft PowerPoint
- Microsoft Excel
- Microsoft Office 365
- Microsoft Outlook
- Microsoft Word
- Mac and PC platforms
- computer applications
- MS Office
- Web applications
- Windows 7
- Windows 2000
Reporting relationship
To be completed by the user of this job description as appropriate
Direct reports (if appropriate)
To be completed by the user of this job description as appropriate
Qualifications
Education
To be completed by the user of this job description as appropriate
Certifications
To be completed by the user of this job description as appropriate
Other relevant qualifications
To be completed by the user of this job description as appropriate
Key Attributes
To be completed by the user of this job description as appropriate
Experience
To be completed by the user of this job description as appropriate
Working conditions (if required)
If the job requires a person to work in special working conditions this should be stated in the job description. Special working conditions cover a range of circumstances from regular evening and weekend work, shift work, working outdoors, working with challenging clients, and so forth.
Physical requirements (if appropriate)
If the job is physically demanding, this should be stated in the job description. A physically demanding job is one where the incumbent is required to stand for extended periods, lift heavy objects regularly, do repetitive tasks with few breaks, and so forth.