Clinical Research Coordinator

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Job Description Summary:

The 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 basic day to day activities related to clinical research studies including: recruit and screen participants, obtains informed consent, educate participants regarding study requirements, event reporting, collection of and organizes research data and complete case report forms. This position applies basic level of understanding to the ability to perform a variety of tasks under direct supervision in a range of different type of clinical studies.

Minimum Qualifications:

Bachelor's Degree (Required)

required from a four year college or university

SPECIALIZED KNOWLEDGE

Ability to prioritize assigned work

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

One year of relevant work or academic experience preferred

Prior experience in a medical environment preferred

Clinical Research Coordinator Certification (or equivalent approved Clinical Research Certification)

One 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

Assists with implementation and coordination of research studies and projects.

Accountable to PI for study specific responsibilities.

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

Assists with protocol feasibility, resource requirements and study panning activities including leading internal training to implement the protocol and avoid deviations.

Assist with recruitment procedures for potential participants and oversee the enrollment of the clinical trial as directed by the PI.

Ensures that study parameters are correctly applied prior to a research participant enrolling a study and during the research participant’s visits and assessments.

Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time period

Attends investigator’s meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives.

Participate in in-house protocol meeting