Clinical Research Coordinator

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Department:
Clinical Research

The Clinical Research Coordinator is responsible for management of Research Studies and Clinical Research Data management.

Research: Under the supervision of the Clinical Research Manager and/or Physician, the Clinical Research Coordinator (CRC) participates in all areas of planning, coordinating and implementing clinical research studies, including regulatory, data collection and entry, and IRB follow-up.

The CRC also assists in the development of other specific research projects presented to, managed, or developed by the SVMHS Clinical Research Department.

Specific responsibilities include: gathering and transcribing data into Case Report Forms, maintaining regulatory paperwork, preservation of investigational product, laboratory supplies and other study-related items; and maintaining database records and reports as needed.

The CRC may provide training, project leadership, and quality control oversight of entry level research coordinators.

The CRC will be capable of coordinating clinical trials in any target therapeutic area, with a particular focus on cardiovascular and oncology clinical trials.

Data Management: This individual will be responsible for assisting in the management of studies such as cancer studies sponsored by the NCI, e.g.

Eastern Cooperative Oncology Group and others.

The CRC assures effective data screening and management necessary to support external data registry submission, monitoring and evaluation functions, physician data, and review functions for the hospital.

Disseminates information as needed in accordance with established HIPAA guidelines.

This position requires a thorough understanding of management of information, and the ability to interact with a wide variety of ethnically diverse people, including patients, their families, physicians, financial staff, clinical staff and information systems.

Utilizes clinical knowledge and assessment skills to identify and screen potential research patients using established criteria.

Enrolls and maintains records of all clinical research patients.



* Demonstrates the ability to coordinate Research and Data activities in a hospital or other setting independently.



* Collaborates with Physicians, clinical staff, IRB and Medical Staff Office and clinical trial sponsors.



* Utilizes positive communication and collaboration skills to affect conflict resolution and teamwork.

Establishes working relationships with physicians, nurses and staff.

Assures clinical staff education on ongoing clinical trials.



* Following Good Clinical Practice (GCP) guidelines, facilitates physiological, psychosocial and spiritual care of the patient within the guidelines of human subjects protection.



* Assists in the coordination of pre-study activities by submitting required documentation, o...