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JOB DESCRIPTION SUMMARY:

The Clinical Research Coordinator 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)

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 carry out the research in an efficient and timely manner.
Assists with protocol feasibility, resource requirements and study planning activities including leading internal training to implement the protocol and avoid deviations.
Assists with recruitment procedures for potential participants and oversees the enrollment of the clinical trial as directed by the PI.
Ensures that study parameters are correctly applied prior to a research participant enrolling in 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.
Participates in 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 required data collection forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation.
Prepares study documents for archiving according to timelines, following closeout visits activities
Responsible for in-depth knowledge of protocol requirements and GCP guidelines.
Performs other related duties as assigned or required.
Patient Care
Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants.
Assists nursing and clinical staff and utilizes knowledge of disease processes to observe, report adverse events, and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant.
Quality and Compliance
Assists in audit preparedness activities for OHRI.
Assists with monitoring visits on site or remotely and is available during visits for corrections, questions, etc.
Maintains study records according to sponsor and/or regulations.
Keep records in a secure location.
Reporting
Assist in the development of reporting metrics.
Generates reports and reviews to ensure validity of data.
Provide ad hoc reports.
Communication
Demonstrates effective communications skills.
Communicates information in a timely and accurate manner.
Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies.
Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers.
Uses various media forms to maximize communication success.
Demonstrates teamwork characteristics.
Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects.
Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level.
Works with research staff to effectively communicate patient process for each trial for the life of the study.
Advise, communicate and reinforce standard practices, regulations to following regarding research study participation.
Other
Attends relevant training courses on policy and compliance.
Ensures assigned training is complete and meets internal qualifications.
Responsible for completing all necessary training for their position.
Maintain familiarity with evolving regulatory and compliance context.
Other duties as assigned.