Senior Clinical Research Coordinator

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Job Description Summary:

The Senior Clinical Consultant Research works in collaboration with the Principal Investigator (PI) to coordinate assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and federal regulations. This position performs day to day activities related to clinical research studies including: recruit and screen participants, obtains informed consent, educate participants regarding study requirements, event reporting and complete case report forms. This position performs activities independently, consistently and accurately and demonstrates skills and abilities resulting in high quality work. This position applies these skills to a broad range of different type of clinical studies, navigates available resources appropriately, effectively uses all tools at their disposal and operates e-technology proficiently. The Senior Clinical Consultant Research performs the majority of activities independently and performs quality checks of their work. This position serves as a formal and informal leader of multidisciplinary teams establishing and maintaining communications with Investigator, research team, sponsor, and other applicable individuals/groups.

Minimum Qualifications:

Bachelor's Degree (Required)

• Degree required from a four year college or university
• Two years of direct human subjects research
• Two years of direct clinical research experience

SPECIALIZED KNOWLEDGE

• Applies critical thinking and creative problem solving skills across a wide variety of clinical studies
• Ability to prioritize the work of multiple projects.
• Experience in a team setting.
• Strong verbal and written communication skills, as well as customer service skills and ability to problem solve, prioritize and manage multiple tasks
• Strong computer skills, including thorough knowledge of systems (EMR, Microsoft)

DESIRED ATTRIBUTES

• Clinical Research Coordinator Certification (or equivalent approved Clinical Research Certification)
• Three or more years of direct human subjects research
• Clinical knowledge in assigned therapeutic area or program

 

MAJOR DUTIES/RESPONSIBILITIES & ESSENTIAL FUNCTIONS

Study Planning and Coordination

Implements the requirements of clinical research protocols in compliance with local, state, institutional, Federal (FDA, DHHS) and sponsor requirements.

Accountable to PI for study specific responsibilities and functions with assistance on multiple clinical research studies.

Works closely with PI to organize, plan and carryout the research in an efficient and timely manner.

Assists with protocol feasibility, resource requirements and study pann