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.

Responsibilities And Duties:

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 panning activities including leading internal training to implement the protocol and avoid deviations.

Develop and plan 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

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.

As needed, organize and/or participate in-house protocol meetings to review study-related procedures, staffing and visit flow.

Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant’s responsibilities in the study.

Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events.

Accurately records and extracts data from source documentation onto report forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation.

After closeout visits have been conducted, prepares study documents for archiving acco