Clinical Research Coordinator II - School of Medicine Neurology

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Description

The Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials.

This position will support an NIH National Institute on Aging (NIA)-funded R01 study, "Improving Residual Sleepiness and Inflammation in Older Adults with OSA: A Randomized Controlled Trial of Citicoline," led by Principal Investigator Dr. Victoria Pak in collaboration with a multidisciplinary team of investigators, including Co-Investigator Dr. Lynn Marie Trotti, Director of the Emory Sleep Center. The coordinator will oversee the day-to-day operations of the study, including participant recruitment, study visits, data collection, biospecimen processing, and regulatory activities.

KEY RESPONSIBILITIES:

Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms.

Provides guidance to less experienced staff.

Interfaces with research participants, determines eligibility and consents study participants according to protocol.

Approves orders for supplies and equipment maintenance.

Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires.

Supervises collection of study specimens and processing.

Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed.

Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors.

Prepares regulatory submissions.

With appropriate credentialing and training may perform phlebotomy or diagnostics.

Performs related approved responsibilities as required.

MINIMUM QUALIFICATIONS:

High School Diploma or GED and five years of clinical research experience.

Or two years of college in a scientific, health related, or business administration program and three years clinical research experience.

Or a licensed as a practical nurse (LPN) and two years clinical research experience.

Or a Bachelor's degree in a scientific, health related, or business administration related program and one year of clinical research experience.

Or a Master's degree, MD or PhD in a scientific, health related or business administration program.

PREFERRED QUALIFICATIONS:

Experience with REDCap, participant recruitment, regulatory documentation, and coordination of clinical trials is strongly preferred.

Phlebotomy certification and experience performing venipuncture and processing biospecimens are strongly preferred.

Employment is contingent upon completion of all required training, credentialing, and background verification, including clinical research orientation and training (e.g., CITI, HIPAA), system training, and AHA BLS certification as applicable to job duties. In addition, employees whose responsibilities require access to EHC facilities must complete a health assessment, drug screening, immunization requirements including annual flu vaccine, competency validation, and any other requirements established by EHC, with ongoing compliance monitored and required for continued employment.

This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher.

NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.

Additional Details

Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD).

Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call 404-727-9877 (Voice) | 404-712-2049 (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.

The Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials.

This position will support an NIH National Institute on Aging (NIA)-funded R01 study, "Improving Residual Sleepiness and Inflammation in Older Adults with OSA: A Randomized Controlled Trial of Citicoline," led by Principal Investigator Dr. Victoria Pak in collaboration with a multidisciplinary team of investigators, including Co-Investigator Dr. Lynn Marie Trotti, Director of the Emory Sleep Center. The coordinator will oversee the day-to-day operations of the study, including participant recruitment, study visits, data collection, biospecimen processing, and regulatory activities.

KEY RESPONSIBILITIES:

Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms.

Provides guidance to less experienced staff.

Interfaces with research participants, determines eligibility and consents study participants according to protocol.

Approves orders for supplies and equipment maintenance.

Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires.

Supervises collection of study specimens and processing.

Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed.

Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors.

Prepares regulatory submissions.

With appropriate credentialing and training may perform phlebotomy or diagnostics.

Performs related approved responsibilities as required.

MINIMUM QUALIFICATIONS:

High School Diploma or GED and five years of clinical research experience.

Or two years of college in a scientific, health related, or business administration program and three years clinical research experience.

Or a licensed as a practical nurse (LPN) and two years clinical research experience.

Or a Bachelor's degree in a scientific, health related, or business administration related program and one year of clinical research experience.

Or a Master's degree, MD or PhD in a scientific, health related or business administration program.

PREFERRED QUALIFICATIONS:

Experience with REDCap, participant recruitment, regulatory documentation, and coordination of clinical trials is strongly preferred.

Phlebotomy certification and experience performing venipuncture and processing biospecimens are strongly preferred.

Employment is contingent upon completion of all required training, credentialing, and background verification, including clinical research orientation and training (e.g., CITI, HIPAA), system training, and AHA BLS certification as applicable to job duties. In addition, employees whose responsibilities require access to EHC facilities must complete a health assessment, drug screening, immunization requirements including annual flu vaccine, competency validation, and any other requirements established by EHC, with ongoing compliance monitored and required for continued employment.

This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher.

NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.

Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD).

Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call 404-727-9877 (Voice) | 404-712-2049 (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.