Clinical Research Coordinator - Sleep Medicine - Ohio Sleep Medicine Institute

Vituity•Columbus, OH

20h•$31•Onsite

About The Position

As a Clinical Research Coordinator, you play a vital role in our mission to improve lives. This individual-contributor role coordinates participant recruitment and informed consent, collects and documents clinical trial data, supports regulatory and safety compliance (including IRB submissions and adverse event reporting), and collaborates with investigators, sponsors, and study staff to ensure studies are conducted in accordance with Good Clinical Practice (GCP) and applicable regulations. At Vituity we know the impact you can have. Join the Vituity Team. At Vituity we’ve cultivated an environment where passion thrives, and success comes through shared purpose. We were founded in a culture that values team accomplishments more than individual achievements, an approach we call “culture of brilliance.” Together, we leverage our strengths and experiences to make a positive impact in our local communities. We foster this through shared goals and helping our colleagues succeed, and we also understand the importance of recognition, taking the time to show appreciation and gratitude for a job well done. Vituity Locations: Vituity has opportunities at 900 practices across the country, serving 14.5+ million patients a year. With Vituity, if you ever need to move, you can take your job with you.

Requirements

Bachelor's degree in a healthcare-related field (e.g., nursing, biology, or related discipline) required.
Candidate must be CPR & Phlebotomy certified required.
Current CPR certification and Phlebotomy certification required.
Working knowledge of ICH Good Clinical Practice (GCP) guidelines and applicable FDA human subjects research regulations required.
Strong knowledge of medical terminology and clinical laboratory procedures
Excellent knowledge with clinical trial processes and regulations
Proficient in using electronic data capture (EDC) systems and clinical trial management software for data entry and tracking.
Excellent organizational skills with the ability to multitask and prioritize workload
Strong attention to detail and accuracy in data collection and documentation
Excellent communication skills, both written and verbal.
Ability to uphold HIPAA regulations and maintain participant confidentiality.
Ability to work independently while following established study protocols and standard operating procedures.
Knowledge of ICH-GCP principles and human subjects protection requirements.

Nice To Haves

1+ years of clinical research coordination experience preferred.
SOCRA (CCRC) or ACRP (CCRC) clinical research certification preferred.
Experience supporting sleep medicine, pulmonary, or neurology clinical trials preferred.
Familiarity with electronic data capture (EDC) systems and IRB electronic submission portals preferred.

Responsibilities

Coordinate study visit scheduling and logistics for enrolled participants from screening through study closeout
Recruit and screen potential study participants
Obtain informed consent from participants and ensure compliance with ethical guidelines
Support recruitment and data collection for sleep medicine clinical trials (e.g., insomnia, obstructive sleep apnea, narcolepsy) in coordination with the Clinical Research Manager and Sleep Medical Director.
Collect and record accurate data during study visits
Perform various clinical procedures such as blood sampling, vital sign measurements, and ECGs
Enter and maintain study data in the sponsor's electronic data capture (EDC) system and resolve data queries in a timely manner
Maintain accurate and up-to-date documentation of study activities.
Ensure compliance with regulatory standards and guidelines
Assist with preparation and submission of IRB applications, protocol amendments, and continuing review documentation
Identify, document, and report adverse events and protocol deviations in accordance with sponsor, IRB, and Good Clinical Practice (GCP) requirements
Prepare source documents and study files for monitoring visits and regulatory inspections, and respond to monitor queries

Benefits

Superior health plan options
Dental, Vision, HSA/FSA, Life and AD&D coverage, and more
Top Tier 401(k) retirement savings plans that offers a $1.20 match for every dollar up to 6% plus discretionary profit-sharing contributions (eligible January following 18 months of service)
Outstanding Paid Time Off: Start at 4 weeks’ PTO, Paid holidays, Sabbatical
Student Loan Refinancing Discounts
Professional and Career Development Program
EAP and travel assistance included
Wellness program
Commuter Benefits Program
Purpose-driven culture focused on improving the lives of our patients, communities, and employees