The Role
Coordinate and support clinical research studies: recruit and consent participants, schedule visits, collect and process specimens and data, maintain source documents and regulatory files, ensure GCP/HIPAA/CLIA compliance, support monitoring/audits, and communicate with investigators, sponsors, and research teams.
Summary Generated by Built In
GENERAL SUMMARY OF DUTIES: United Digestive’s (UD) Clinical Research Coordinator is responsible for assisting the Research Department and Primary Investigators with all clinical and organizational tasks for research projects and protocols. He/she is expected to exhibit basic knowledge of clinical research activities and adhere to federal and other applicable regulations, including ensure compliance with protocol guidelines, identify problems and/or inconsistencies and monitoring subject’s processes throughout the clinical research study.
RESPONSIBILITIES:
Duties include but are not limited to:
Duties include but are not limited to:
- Recruit and screen potential research participants.
- Obtain and document informed consent.
- Educate patients regarding study-specific participation, benefits, and risks.
- Coordinate study visits and protocol-required procedures.
- Collect clinical research data and perform study assessments.
- Collect, process, document, and ship study specimens.
- Maintain accurate source documents and study records.
- Review study data and resolve documentation discrepancies.
- Prepare and maintain regulatory documentation and submissions.
- Support monitoring visits, audits, and sponsor communications.
- Maintain research equipment, supplies, and study materials.
- Ensure compliance with protocols, HIPAA, GCP, CLIA, and applicable regulations.
- Adhere to infection control and patient safety standards.
- Respond to participant and internal inquiries promptly and professionally.
- Collaborate with investigators, sponsors, and research staff.
- Participate in required meetings, training, and continuing education.
- Cross-train and support additional research activities as assigned.
- Perform special projects and other duties as assigned.
EDUCATION, SKILLS, & EXPERIENCE:
- Required:
- Bachelor’s degree required.
- Minimum one (1) year of clinical research experience required.
- Ability to obtain ARUP Handling, Packaging and Shipping Infectious Materials certification (or equivalent) within 30 days of employment.
- Ability to obtain Collaborative Institutional Training Initiative (CITI) certification within 30 days of employment.
- Proficiency with Microsoft Office applications, electronic health records, and research-related software systems.
- Knowledge of clinical research regulations, protocol compliance, patient confidentiality practices, and Good Clinical Practice (GCP) guidelines
- Ability to work independently while maintaining high attention to detail and organizational standards.
- Proven customer service skills and commitment to providing exceptional patient care.
- Ability to remain professional and composed in a fast-paced clinical environment.
- Preferred:
- Certified Medical Assistant (CMA) certification or Licensed Practical Nurse (LPN) license.
- Minimum two (2) years of clinical healthcare experience.
- Experience with phlebotomy, specimen collection, processing, and shipping.
- Basic Life Support (BLS) certification
- Strong verbal and written communication skills with patients, investigators, and research teams.
WORK ENVIRONMENT:
Requires sitting and standing associated with a normal office environment. Travel required as business needs dictate.
Requires sitting and standing associated with a normal office environment. Travel required as business needs dictate.
DRUG FREE WORKPLACE:
United Digestive is a drug-free workplace. All offers of employment are contingent upon passing a pre-employment drug screening.
United Digestive is a drug-free workplace. All offers of employment are contingent upon passing a pre-employment drug screening.
EQUAL OPPORTUNITY EMPLOYER:
United Digestive is an equal opportunity employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, veteran status, genetic information or any other legally protected classification or status.
United Digestive is an equal opportunity employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, veteran status, genetic information or any other legally protected classification or status.
Skills Required
- Bachelor's degree
- Minimum one (1) year of clinical research experience
- Obtain ARUP Handling, Packaging and Shipping Infectious Materials certification within 30 days
- Obtain CITI certification within 30 days
- Proficiency with Microsoft Office applications, electronic health records, and research-related software systems
- Knowledge of clinical research regulations, protocol compliance, patient confidentiality practices, and Good Clinical Practice (GCP) guidelines
- Ability to work independently with high attention to detail and organizational standards
- Proven customer service skills and commitment to providing exceptional patient care
- Ability to remain professional and composed in a fast-paced clinical environment
- Certified Medical Assistant (CMA) certification or Licensed Practical Nurse (LPN) license
- Minimum two (2) years of clinical healthcare experience
- Experience with phlebotomy, specimen collection, processing, and shipping
- Basic Life Support (BLS) certification
- Strong verbal and written communication skills with patients, investigators, and research teams
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The Company
What We Do
United Digestive is an Atlanta-based physician practice management company focused on delivering value for GI physicians and gastroenterology practices nationwide. The company serves independent practices by leveraging advanced operational infrastructure and insights to reduce administrative burden, while supporting clinicians' objective to provide the highest-quality patient care.
