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Coordinator Clinical Trial Cumberland Atlanta, GA



Description

Coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with direction from the principal investigator and/or supervisor in compliance with regulatory laws and KPGA guidelines. Collaborates with research team to assess feasibility and management of research protocols. Ensures implementation of research protocols after IRB approval and provides information as appropriate for progress reports. Screens, enrolls, and recruits research participants. Coordinates schedules and monitors research activities and subject participation. Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Manages, monitors, and reports research data to maintain quality and compliance. Provides education/training for others within the department. Performs administrative and regulatory duties related to the study as appropriate. Maintains knowledge of policies and procedures and performs in accordance with applicable regulatory requirements, external laws and accreditation standards as they relate to research.


Essential Responsibilities:
- Coordinates complex clinical research protocols with direction from the principal investigator and/or supervisor in compliance with regulatory and KPGA guidelines, including Assists in the development and design of research data collection tools, working with clinic staff to ensure ease of research project implementation, and project start up. Delivers the study intervention that may include obtaining patient informed consent and other specific protocol tasks as appropriate. In collaboration with investigator and/or site supervisor, coordinates day-to-day progress of research studies. Records research data in case report form, if required. Responsible for the documentation and reporting of adverse events. Monitors and follows-up on research subjects. Documents all research subject visits, site visits, study meetings.
- Manages, monitors, and reports research data to maintain quality and compliance. Assure timely and accurate data handling. Assists in data quality monitoring. Assist in designing data collection or abstraction forms. Maintains regulatory binders, if required. Assists with internal/external compliance monitoring and/or audits and inspections to protect research participants, assure operational effectiveness, and to reduce risks to the organization. Communicates with project manager or investigator and supervisor regarding study task progress.
- Travel to the Regional office and other medical office buildings required for education/training, participant recruitment, participant study visits, and meetings.
- May perform other duties as assigned by appropriate management.

Qualifications:

Basic Qualifications:
Experience
- Minimum three (3) years ofexperience as a clinical research coordinator working with patients and/or research participants.
Education
- Bachelor's degreeOR four (4) years of experience in a directly related field.
- High School Diploma or General Education Development (GED) required.
License, Certification, Registration
- N/A

Additional Requirements:
- Effective written and verbal communication skills.
- Familiarity with database software.
- Ability to multitask, plan, organize and prioritize projects.
- Excellent interpersonal skills.
- Ability to work independently.
- Proficient in medical terminology.
- Prior experience working with electronic health records.
- Preference will be given to candidates with clinical research certification such as SoCRA or ACRP.

Preferred Qualifications:
- Master's degree.

Primary Location: Georgia,Atlanta,Cumberland Medical Offices 2525 Cumberland Pkwy.

Scheduled Hours (1-40): 40

Shift: Day

Working Days: Mon-Fri

Schedule: Full-time

Job Type: Standard

Employee Status: Regular

Employee Group: Non-Union, Non-Exempt

Job Level: Entry Level

Job: Research and Development

Public Department Name: Center for Clinical & Outcomes Research


External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.

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