POSITION SUMMARY
Research Coordinator II assists investigators with the coordination of cardiovascular clinical research projects in compliance with the approved protocol, institutional policies and procedures, and Federal regulations. Collects and records data, maintains study binders and other related files, and prepares and submits (as approved by the PI) documents and reports related to assigned projects.

PRIMARY RESPONSIBILITIES

• Assists investigators, as appropriate, with coordination of study per the IRB approved protocol.
• Recruits and screens potential study participants for current IRB-approved protocols.
• Obtains informed consent as directed by the principal investigator using the current IRB-approved consent form; communicates effectively with study participants as necessary.
• Schedules participants for screening, follow up, and protocol-required tests and procedures.
• Organizes and maintains research participant study binders by filing all correspondence and forms.
• Maintains logs of screened and enrolled participants and provides updates to sponsors as required per protocol.
• Retrieves research data including medical records as required by the research protocol.
• Accurately transcribes clinical research data into study case report forms and other documents per current IRB-approved protocol.
• Actively maintain, track, and certify research protocol activities and patient profiles in the institutional clinical trial management system (CTMS).
• Records and documents protocol deviations.
• Completes and returns sponsor queries within required timeframes and meets complex expectations of sponsors.
• Identifies, documents, and effectively communicates adverse events to PI, study sponsor and IRB as required.
• Operates study-specific equipment (may include investigational devices) and provides technical assistance (as to protocol) to other staff involved in use of study equipment, devices and/or drugs. May include training other staff in proper operation and use of investigational devices.
• Prepares and processes specimens for shipment to appropriate laboratory per protocol requirement.
• Assists investigators, study monitors and others during protocol audits; includes providing necessary documents.
• Works with manager to develop study budget, as needed.
• Works with hospital and other staff to help ensure that research billing is appropriate, and the details are distributed as instructed.
• Serves as liaison between patients, hospital departments, and other personnel to ensure efficient management of study protocol.
• IRB submissions including initial protocol, amendments, renewals, closeouts, and other IRB submissions as required by the protocol in addition to regulatory binder maintenance.
• Adheres to Good Clinical Practices, Code of Federal Regulations relating to clinical trials, and ICH Guidelines; knowledge of HIPAA requirements, and knowledge of OSHA Bloodborne Pathogen Standards.
• Abides by all Standard Operating Procedures and Policies of The Texas Heart Institute.
• Performs other job-related duties as assigned.

EDUCATION REQUIREMENTS

• Bachelor’s degree or 3 years’ equivalent experience in clinical research
• Three (3) years of relevant clinical research experience required
• Work towards clinical research certification as CCRC or CCRP upon hire
• Must have completed Institute-required clinical research training program upon employment, or if not, will be required to complete such training within 30 days of employment
• Must possess excellent written and verbal communication skills
• Ability to coordinate all aspects of research study

COMPUTER SKILLS

• Knowledge of Microsoft products (Word, Excel, PowerPoint, Outlook) is required.
• Experience with Clinical Conductor.