Research Coordinator Jobs

About The Position

Requirements

• Bachelor's degree from a four-year college or university.
• Ability to prioritize assigned work.
• Strong verbal and written communication and customer service skills.
• Ability to problem-solve, prioritize, and manage multiple tasks.
• Strong computer skills, including thorough knowledge of EMR and Microsoft systems.

Nice To Haves

• 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 experience.
• Clinical knowledge in the assigned therapeutic area or program.

Responsibilities

• Assist with implementing and coordinating research studies and projects; remain accountable to the PI for study-specific responsibilities.
• Work with the PI and direct supervisor to organize and carry out research efficiently and on time.
• Assist with protocol feasibility, resource planning, study planning, and internal training to implement protocols and avoid deviations.
• Assist with participant recruitment and oversee clinical trial enrollment as directed by the PI.
• Ensure study parameters are correctly applied before enrollment and during participant visits and assessments.
• Extract and accurately record physical findings, laboratory data, and other study details on required data collection forms within designated timelines.
• Attend investigator meetings, pre-study site visits, study initiation visits, and other study-related visits by monitors or sponsor representatives; some pre-study visits may require travel.
• Participate in protocol meetings to review study procedures, staffing, and visit flow.
• Participate in the informed consent process with the Investigator, ensuring participants and, when applicable, families have questions answered and understand the consent form and study responsibilities.
• Instruct participants and serve as their primary contact for study-specific questions, concerns, or events.
• Record and extract data from source documentation onto paper or electronic forms and maintain accurate, timely source documentation.
• Prepare study documents for archiving after closeout visits, according to timelines.
• Maintain in-depth knowledge of protocol requirements and GCP guidelines.
• Assist nursing and clinical staff in facilitating participant care; observe and report adverse events and protocol violations or deviations promptly and accurately to the Investigator.
• Assist with OHRI audit preparedness and study monitoring visits, including being available to address corrections and questions.
• Maintain study records according to sponsor requirements and regulations, and keep records in a secure location.
• Assist in developing reporting metrics, generate reports, review data validity, and provide ad hoc reports.
• Communicate accurately and promptly; serve as a liaison between sponsors and investigators regarding study preparation, execution, and completion.
• Adapt communication to different situations and communication barriers; demonstrate teamwork and use appropriate media to support communication.
• Manage time, prioritize work, follow up on projects, and remain flexible across multiple projects.
• Participate in meetings with OHRI, the PI, and clinical teams to review patient status, and work with research staff to communicate patient processes throughout each trial.
• Advise, communicate, and reinforce standard practices and regulations relating to research study participation.
• Attend relevant policy and compliance training, complete assigned training and position requirements, and maintain familiarity with evolving regulatory and compliance requirements.
• Perform other duties as assigned or required.