Clinical Research Coordinator I - CardioVascular

Job Overview

Job Profile Summary

Duties and Responsibilities

Minimum Qualifications

Preferred Qualifications

Skills & Abilities

Physical Requirements

Pay Range

• About the role

  This position will assist the Principal Investigators (PIs) and Cardiovascular Director of Clinical Research in planning and implementing clinical research studies as assigned.

• Responsibilities

  Supports the development of new products and innovation. Includes Clinical roles focused on research projects. Responsible for assisting in the recruitment of study participants. Organizes strategies for recruiting study participants, and screening study 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. Complies with all institutional policies and government regulations pertaining to human subjects’ protections. Responsible for assisting with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews. 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. Coordinates resolution of all data queries. Completes data entry as warranted. 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. Physical Requirements: Typical clinical and administrative office setting. Skills & Abilities: High degree of organizational talents, data collection and analysis skills. Requires meticulous attention to detail. Excellent computer skills including word processing. Ability to prioritize quickly and appropriately. Excellent communication and interpersonal skills. Systematic record-keeping.

• Requirements

  Minimum Qualifications: Bachelor’s degree OR High School Diploma or equivalent AND Four (4) years of related experience. Basic Life Support (BLS) certification may be required based on specific role requirements. Two (2) years in research related activities. Preferred Qualifications: Five (5) years in research related activities. Previous experience in clinical trials.

• Qualifications

  Bachelor’s degree OR High School Diploma or equivalent AND Four (4) years of related experience. Basic Life Support (BLS) certification may be required based on specific role requirements. Two (2) years in research related activities. Five (5) years in research related activities. Previous experience in clinical trials.

• Skills

  High degree of organizational talents, data collection and analysis skills. Requires meticulous attention to detail. Excellent computer skills including word processing. Ability to prioritize quickly and appropriately. Excellent communication and interpersonal skills. Systematic record-keeping.

• Physical Requirements

  Typical clinical and administrative office setting.

• Pay Range

  $44,778.55 - $55,978.47