Clinical Research Coordinator III - Grant Funded - Cardiology

Carilion Clinic•Roanoke, VA

1d•Onsite

About The Position

The Clinical Research Coordinator will support clinical trials in the Department of Cardiology at Carilion Clinic. Basic responsibilities include supporting research investigators/physicians with guidance on research policies and processes, enabling successful collaborations with research sponsors, monitoring and tracking study progress, study design assistance, regulatory submission and maintenance, research subject visit management, and any other research-related duties, as necessary. Under the supervision of the Department of Medicine Clinical Research Unit, this position is charged with maintaining compliance with study protocols, guidelines set by governing agencies, and institutional policy. Clinical Research Coordinator career ladder placement at hire ranges from level I-IV based on experience, certification, and education. Advancement opportunities are available based on experience, certification, education, and competency level. Candidates Should Possess the Following Qualities: Detail-oriented Organized Comfortable in a fast-paced environment Able to balance multiple priorities Motivated by challenges Compassionate towards patients and their families/caregivers The Clinical Research Coordinator manages administrative activities associated with the conduct of research studies including industry sponsored, grant funded or internally funded studies while maintaining compliance with guidelines set by governing agencies and institutional policy. Serves as liaison between research sponsors, site management organizations, local Institutional Review Board (IRB), physicians/staff, and R&D. Recruit, screen, and enroll eligible study participants. Obtain informed consent from study participants. Manages completion and submission of study related documentation. Communicates with research sponsor or CRO, local or central IRB, Research and Development, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance. Monitors enrollment goals and implements action plans, as needed. Coordinates tasks such as developing informed consents and screening materials, scheduling visits, and acting as a liaison between research participants and the research study team. Collects data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Collect, process, and ship research specimens as directed in the protocol. Ensure compliance with study protocol and requirements of regulatory agencies. Tracks and reports adverse events and protocol deviations. Coordinates all site related monitoring or auditing visits from sponsor or federal agency during the course of the study and at closure. Prepares, submits, and maintains IRB, R&D, FDA and/or any other funding or regulatory documents and research correspondence. Develops and maintains patient databases and study maintenance logs including but not limited to training logs, delegation of responsibility logs, screening logs, enrollment logs, and investigational product log. Demonstrates competency managing multiple complex studies and greater workload. Provides in-depth clinical research training and mentorship to junior CRCs. Contributes to trial planning, development, and implementation activities. Provides education and support throughout the research process to all members of the research team and to ancillary departments involved in research. Assists with protocol feasibility determination, identifying potential barriers and proactively solving problems. Assists in developing data collection systems and compiling study-related reports. Assists in writing research grant proposals, manuscripts, study materials, brochures, and correspondence.

Requirements

Bachelor's degree in science or related field required. Master’s Degree preferred.
Minimum of three (3) years of Clinical Research (or equivalent research experience) AND a Master’s Degree in Science or related field OR Minimum of five (5) years of Clinical Research (or equivalent research experience) AND a Bachelor’s Degree in Science or related field required.
Nationally recognized clinical research certification from Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) required upon hire.
I.A.T.A. (International Air Transport Association) certification is required for projects that will be transporting specimens prior to completion of IRB application.
Excellent computer skills; strong knowledge of word processing, spreadsheets, databases, and internet environment.
Knowledge of medical and/or pharmaceutical terminology strongly desired.
Strong organization and communication skills required.
Able to work with multiple interruptions and to perform multiple tasks at any given time.
Must have strong leadership, interpersonal and teamwork skills.

Responsibilities

Supports research investigators/physicians with guidance on research policies and processes
Enables successful collaborations with research sponsors
Monitors and tracking study progress
Study design assistance
Regulatory submission and maintenance
Research subject visit management
Maintains compliance with study protocols, guidelines set by governing agencies, and institutional policy
Manages administrative activities associated with the conduct of research studies including industry sponsored, grant funded or internally funded studies
Serves as liaison between research sponsors, site management organizations, local Institutional Review Board (IRB), physicians/staff, and R&D
Recruits, screens, and enrolls eligible study participants
Obtains informed consent from study participants
Manages completion and submission of study related documentation
Communicates with research sponsor or CRO, local or central IRB, Research and Development, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance
Monitors enrollment goals and implements action plans, as needed
Coordinates tasks such as developing informed consents and screening materials, scheduling visits, and acting as a liaison between research participants and the research study team
Collects data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources
Collect, process, and ship research specimens as directed in the protocol
Ensures compliance with study protocol and requirements of regulatory agencies
Tracks and reports adverse events and protocol deviations
Coordinates all site related monitoring or auditing visits from sponsor or federal agency during the course of the study and at closure
Prepares, submits, and maintains IRB, R&D, FDA and/or any other funding or regulatory documents and research correspondence
Develops and maintains patient databases and study maintenance logs including but not limited to training logs, delegation of responsibility logs, screening logs, enrollment logs, and investigational product log
Demonstrates competency managing multiple complex studies and greater workload
Provides in-depth clinical research training and mentorship to junior CRCs
Contributes to trial planning, development, and implementation activities
Provides education and support throughout the research process to all members of the research team and to ancillary departments involved in research
Assists with protocol feasibility determination, identifying potential barriers and proactively solving problems
Assists in developing data collection systems and compiling study-related reports
Assists in writing research grant proposals, manuscripts, study materials, brochures, and correspondence