Clinical Research Coordinator II - G&C - Cardiology

Job Description

This position is responsible for the development and implementation and reporting for research protocols under the supervision of the Principal Investigator.

The Tufts Cardiovascular Research Institute (CVCRI) conducts a wide range of clinical trials in all areas of cardiology including heart failure, electrophysiology, interventional cardiology, hypertrophic cardiomyopathy, arterial and venous diseases, and wound healing.

The CVCRI is seeking to add a new member to their team responsible for the implementation, management, and administration of multiple clinical trials in heart failure. This position will work collaboratively with a team of Principal Investigators and clinical research team members on several drug and device studies. Prior clinical research experience is required.

• Work as part of one or more project teams and remain proficient in designing and managing research.
• Perform study start-up and continuing review activities – prepares regulatory documents and submission to the IRB (local and WIRB). Participate with PI in writing or revising of protocols, DSMB, Manual of Operations. Assist with application for IND. Submit documents to FDA as needed.
• Coordinate and attend sponsor prequalification visits, monitor visits, and study termination visits.
• Responsible for assisting in the recruitment of study participants. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements. Reviews all eligibility and ineligibility criteria in the patient’s record. Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.
• Organizesstrategies for recruiting study participants, and screeningstudy participants for eligibility on the telephone, in the clinic and other settings as required.
• Completes follow up with study participants in prescribed settings as required.
• Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods. Conducting a QC check of completed CRFs prior to submission for data entry; coordinatingresolution of all data queries. Completing data entry as warranted.
• Complies with all institutional policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.
• Performs basic laboratory activities as needed.
• Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.
• Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.
• Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
• Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests,etc.
• Organizes and participates in site visits with the study sponsor to review completeness and accuracy of study documentation.
• Maintains inventory of all study supplies.

Qualifications

• BS or equivalent.
• 2-5 years of clinical research experience.
• Highly self-motivated candidate, with the ability to function independently.
• Excellent organizational and communication skills are essential.
• High degree of organizational talents, data collection and analysis skills. Requires meticulous attention to detail.

Additional Information

Must be able to perform all essential functions of this position with reasonable accommodation if disabled.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Tufts Medical Center reserves the right to modify position duties at any time, to reflect process improvements and business necessity.

All your information will be kept confidential according to EEO guidelines.