Job description

Blue Ridge Medical Research, a division of Gastroenterology Associates of Central Virginia, is seeking a responsible professional for the position of CLINICAL RESEARCH/STUDY COORDINATOR to conduct clinical trials for various gastrointestinal conditions with the goal of providing enhanced treatments for patients who may not get adequate relief from their current medical regimen. All studies are conducted under the excellent care of trained physicians, nurses, and research staff, as well as monitored by the U.S. Food and Drug Administration and its affiliates.

JOB SUMMARY: The Clinical Research Coordinator is the heart of the Research department, managing multiple studies, recruiting and screening study subjects for eligibility, participating in the informed consent process, scheduling and conducting study visits and procedures, dispensing study drug, and meticulously documenting and entering results while ensuring compliance with the Food and Drug Administration (FDA).

EDUCATION: B.A./B.S. degree in health sciences or related field, nursing degree, or a diploma/certification in an associated medical field is required.

EXPERIENCE: Previous experience with clinical trials at an investigative site desired.

ESSENTIAL SKILLS AND ABILITIES: Meticulous attention to detail and organizational skills, along with the ability to keep accurate and timely records are required, along with effective verbal and written communication skills with patients, staff, and other healthcare professionals. Must be able to function effectively in a team setting. Phlebotomy certification or experience is a necessity. Strong computer skills, including proficiency in Microsoft Office systems are required.

RESPONSIBILITIES:

· Become familiar with all study protocols.

· Maintain research subject safety, welfare, and confidentiality according to HIPAA regulations and applicable law.

· Coordinate and manage all daily activities of the study following established protocol.

· Prescreen, recruit, and interview study subjects to ensure study eligibility and understanding.

· Explain and obtain subject informed consent according to federal regulations, ICH guidelines, GCP, SOPs, and Sponsor/CRO and IRB requirements.

· Schedule participants for research visits and procedures and conduct visits according to study protocol.

· Conduct study-related assessments including the collection and processing of lab samples.

· Perform timely and accurate data collection, source documentation, EDC-entry, and query resolution for all research visits and procedures.

· Dispense study drug and instruct subjects on accurate dosing per protocol and perform accountability post drug return.

· Maintain accountability of study materials (lab kits, study drug, and supplies).

· Perform other duties, as assigned.

Benefit Conditions:

• Waiting period may apply
• Only full-time employees eligible

This Company Describes Its Culture as:

• Detail-oriented -- quality and precision-focused
• Team-oriented -- cooperative and collaborative

Work Remotely

• No

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Associate (Required)

Work Location: One location

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