Clinical Research Coordinator III

Performance Expectation:  Initiates studies  Coordinates and facilitates site qualification visits;  Assists in evaluation of all potential clinical research studies;  Exhibits a working knowledge of the protocol, including background, rationale and description of investigational drug/device;  Understands inclusion/exclusion criteria;  Understands visits, tests, procedures and concomitant medications per protocol;  Knowledgeable and confident to perform informed consent process including multiple consenting when appropriate;  Maintains communication with sponsor representatives, including acquisition of case report forms, device and/or drug stock, study tools and related documents;  

Maintains current inventory logs;  Identifies study specific tests and procedure protocols, contacts appropriate departments and facilitates required training, certification and validation;  Coordinates and facilitates site initiation visits;  Assesses protocol requirements for patient care and provides necessary instruction;  Collaborates with principal investigator to identify standard of care vs. nonstandard of care visits, hospitalizations, tests and procedures;  Assembles, updates and maintains study packets, including consent, inclusion/exclusion check list, sponsor contact information and other related information;  

Prepares and distributes study specific flyers for ancillary staff and departments;  Coordinates in-service/training/proctoring for physicians, departments and appropriate staff with supervision; and  Ensures accurate progress of the protocol from planning to closure.
Performance Expectation:  Enrolls patients  Diligently screens for patients in appropriate departments and participating physician offices;  Completes and submits screening forms;  Enters screen failures in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements;  Maintains contact with principal investigators and sub-investigators to promote study and encourage patient enrollment;  Available and prepared for patient enrollment;  Promotes protocol compliance by being in clinic/physician’s office/lab/OR when the subject is seen or leaves guidelines for investigator or sub-investigator to follow;  

Notifies and schedules sponsor clinicians, engineers and/or proctors for cases as necessary;  Orders all protocol required labs, tests, procedures and medications accurately and according to VCU Health/VCU and area of responsibility SOPs;  Manages studies prospectively to prevent protocol deviations;  Enters patient enrollments and completes check list in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements;
Communicates regularly with PI, research nurse, and RCII team to ensure smooth and accurate enrollments; and  Maintains screening and enrollment logs and provides to sponsor within established timeframe.

Who We Are    Inventing better care, day by day by discovery
We’ll do whatever it takes to offer the best in care and empower the best in quality of life. And it’s an approach that works — whether it’s a patient who undergoes a new, life-saving procedure or a clinical researcher who finds promise in a new cancer treatment, exciting new medicine is happening at VCU Health.
We have it all:  
• One college and four health sciences schools  
• An academic medical center  
• A Level I trauma center  
• One of only two NCI-designated cancer centers in Virginia  
• The region’s only full-service children’s hospital  
• More than 800 physicians in 200 specialties  
• With a community health center, dedicated research teams, facilities and valued partners in every field    Our medical teams are top notch. And we’re not too shy to boast of internationally known physicians, some recognized as the best in the country, top-ranked local specialists and all-around all-stars at every level. From our very first years to our most recent advancements, we are driven to learn more, dig deeper, teach passionately and never rest in order to be a true leader in discovering what’s possible in health and recovery.

We are a comprehensive system of care and a pioneer of health. Read VCU Health Year In Review for more about our accomplishments.
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