POSITION SUMMARY
Research Coordinator I 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 principal investigators with development of clinical research protocols, consent forms, and related documents according to institutional and IRB policies and procedures, and FDA regulations.
• Assists investigators, as appropriate, with coordination of study according to the approved protocol, and obtains research data from multiple sources, including medical records, hospital computer system and department forms.
• Obtains informed consent as directed by the principal investigator, in compliance with institutional policies and regulations and using the IRB-approved consent form; communicates effectively with study subjects as necessary.
• Completes study case report forms and other documents according to approved protocol with strict adherence to timelines set out by sponsor.
• Maintains study files (patient binders, regulatory binders) according to Good Clinical Procedures for clinical research (GCP), and in an organized manner to maintain up to date status.
• Maintains database and logs of patients enrolled into studies and produces summary reports of ongoing clinical research programs. Distributes reports to key personnel as directed.
• 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.
• Assists investigators, study monitors and others during protocol audits; includes providing necessary documents. Liaison to study monitors to provide necessary study documents and coordinator time for successful visits.
• Assists investigators with preparation of presentations and publications of study results.
• Works with manager to develop study budget. 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.

EDUCATION REQUIREMENTS

• Bachelor’s degree or 2 years’ equivalent experience in clinical research
• (2) 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.