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BSD MED - Hospital Medicine - Clinical Research Staff - Hospitalist

About the Department

The Clinical Research Coordinator 1 will be a member of research in Hospital Medicine, working on projects for the Hospitalist Project. Hospital Medicine research is responsible for establishing standards, operating procedures, policies and practices, implementing educational and training programs, developing communication tools, and managing the administrative functions that impact individuals involved in clinical research. The Clinical Research Coordinator 1 will provide support to the research faculty in the section of Hospital Medicine and within the Department of Medicine.

Job Summary

The Clinical Research Coordinator 1 (CRC1) is an entry level researcher working with the Principal Investigator (PI) Dr. David Meltzer, Co-Investigator(s) and other study personnel, and under the limited direction of departmental, Research Director. The CRC1 works with the PI, Co-Investigator(s), department, sponsoring agencies, and/or the to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study.

Responsibilities

• Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
• Organizes and attends site visits from sponsors and other relevant study meetings.
• Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF\'s), drug dispensing logs, and study related communication.
• Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions.
• Understand the federal research regulations and identify the federal research organizations\' role in regulating human research participation.
• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
• Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through ---

Certifications:

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Preferred Qualifications

Education:

• Bachelors degree.

Experience:

• Knowledge of medical terminology/environment.

Preferred Competencies

• Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
• Ability to communicate with tact and diplomacy.
• Strong organizational skills.
• Strong communication skills (verbal and written).
• Excellent interpersonal skills.
• Strong data management skills and attention to detail.
• Knowledge of Microsoft Word, Excel and Adobe Acrobat.
• Re d and understand complex documents (e.g., clinical trials).
• Handle competing demands with diplomacy and enthusiasm.
• Absorb large amounts of information quickly.
• Adaptability to changing working situations and work assignments.

Application Documents

• Resume (required)
• Cover Letter (required)

When applying, the document(s) MUSTbe uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family

Research

Role Impact

Individual Contributor

FLSA Status

Exempt

Pay Frequency

Monthly

Scheduled

Weekly Hours

37.5

Benefits Eligible

Yes

Drug Test Required

Yes

Health Screen Required

Yes

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