Clinical Research Coordinator

Key Responsibilities

• Study Planning and Coordination

• Assists with the implementation and coordination of research studies and projects.

• Accountable to the Principal Investigator (PI) for study-specific responsibilities.

• Works closely with the PI and direct supervisor to organize, plan, and carry out research efficiently and in a timely manner.

• Assists with protocol feasibility, resource requirements, and study planning activities, including leading internal training to implement protocols and avoid deviations.

• Assists with recruitment procedures for potential participants and oversees enrollment in clinical trials as directed by the PI.

• Ensures study parameters are correctly applied before participant enrollment and during participant visits and assessments.

• Extracts and records physical findings, laboratory data, and other essential study details onto required data collection forms accurately and within designated timelines.

• Attends investigator's meetings, pre-study site visits (may require travel), study initiation visits, and 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 participants and their families have questions answered and understand the consent form and their responsibilities.

• Serves as the primary contact for subjects, providing participant instructions and 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 visit activities.

• Maintains in-depth knowledge of protocol requirements and Good Clinical Practice (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 and report adverse events, protocol violations, or deviations in a timely and accurate manner to the Investigator to ensure participant health, safety, and welfare.

• 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 or questions.

• Maintains study records according to sponsor and/or regulations.

• Keeps records in a secure location.

• Reporting

• Assists in the development of reporting metrics.

• Generates reports and reviews them to ensure data validity.

• Provides ad hoc reports.

• Communication

• Demonstrates effective communication skills.

• Communicates information in a timely and accurate manner.

• Functions as a liaison with sponsors and investigators regarding the preparation, execution, and completion of studies.

• Adapts communication skills in response to various situations, including 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, with 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 processes for each trial throughout the study's lifecycle.

• Advises, communicates, and reinforces standard practices and regulations 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.

• Maintains familiarity with the evolving regulatory and compliance context.

• Other duties as assigned.

• As a High Reliability Organization (HRO), responsibilities require focus on safety, quality, and efficiency in performing job duties.

Requirements & Tech Stack

• GCP guidelines
• Federal regulations
• Good Clinical Practice (GCP) guidelines
• EMR (Electronic Medical Record) systems
• Microsoft systems

Qualifications

• Bachelor's Degree (Required)
• Ability to prioritize assigned work.
• Strong verbal and written communication skills.
• Strong customer service skills.
• Ability to problem-solve, prioritize, and manage multiple tasks.
• Strong computer skills, including thorough knowledge of systems.
• 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.