Clinical Research Coordinator III

The Clinical Research Coordinator II is responsible for all aspects of conducting Phase I, II, III, and IV clinical trials for children, adult, and/or geriatric patients within internationally accepted standards of knowledge and understanding of the clinical research process and related regulations. The position duties include administrative and clinical study initiation processes, enrollment of patients, data collection, managing study patient follow-up, coordination of monitoring visits, and other administrative duties. The CRC II will also be a resource on general and VCU Health/VCU-specific clinical research processes for junior clinical research staff as well as University and health system staff.

Essential Job functions 

Performance Expectation:  Exhibit advanced competencies required to conduct clinical research
Maintains an intermediate knowledge and understanding of the research process and related regulations;
Maintains CCRC certification;
Maintains membership in one (1) professional organization or hospital committee or high-profile activity;
Maintains an intermediate level of knowledge including anatomy, disease process, medical terminology, tests and procedures relating to area of responsibility;
Receives a minimum of 24 contact hours per year related to clinical research or job-related discipline documented by certificates of continuing education credits;
Exhibits a high skill level of Microsoft Office and enrolls in classes as needed to achieve this level;
Exhibits a high level of proficiency in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements; 
Develops a system for organizing, planning and controlling work-flow as related to specific activities with meticulous attention to detail and ordering of priorities; and
Proven to function independently and proficiently as defined in the position essential functions with minimal supervision.

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
Mai