Senior Clinical Research Coordinator

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About the role

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 independently, consistently, and accurately, demonstrating skills and abilities resulting in high-quality work. The role applies these skills to a broad range of clinical studies, navigates resources effectively, and operates e-technology proficiently. The Senior Clinical Consultant Research serves as a formal and informal leader of multidisciplinary teams, establishing and maintaining communications with investigators, research teams, sponsors, and other applicable individuals or groups.

Responsibilities

• 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 the PI for study-specific responsibilities and functions across multiple clinical research studies.
  • Works closely with the PI to organize, plan, and carry out research efficiently and timely.
  • Assists with protocol feasibility, resource requirements, and study planning activities, including leading internal training to implement protocols and avoid deviations.
  • Develops and plans recruitment procedures for potential participants and oversees enrollment as directed by the PI.
  • Ensures study parameters are correctly applied before and during participant visits and assessments.
  • Extracts and records physical findings, laboratory data, and other study details onto required data collection forms accurately and within designated timeframes.
  • Attends investigator meetings, pre-study site visits (which may require travel), study initiation visits, and other study-related visits by monitors or sponsor representatives.
  • Organizes and/or 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 understand the consent form and their responsibilities.
  • Serves as the primary contact for participants, addressing 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.
  • Prepares study documents for archiving after closeout visits.
  • Demonstrates in-depth knowledge of protocol requirements and GCP guidelines.
• Patient Care
  • Works with nursing and clinical staff to facilitate the care of research participants.
  • Utilizes knowledge of disease processes to observe, report adverse events, and protocol violations/deviations in a timely and accurate manner to the Investigator.
• Quality and Compliance
  • Assumes responsibility for audit preparedness activities.
  • Oversees the preparation of records for periodic audits by sponsors, CROs, regulatory agencies, and internal reviews.
  • Assists with on-site monitoring visits and is available for corrections or questions during visits.
  • Maintains study records according to sponsor and/or regulatory requirements in a secure location.
• Reporting
  • Assists in the development of reporting metrics.
  • Generates and reviews reports to ensure data validity.
  • Provides ad hoc reports as needed.
• Communication
  • Demonstrates effective communication and leadership skills.
  • Communicates information accurately and timely with minimal supervision.
  • Functions as a liaison with sponsors and investigators regarding study preparation, execution, and completion.
  • Adapts communication skills to various situations, including cultural, age, education, and other barriers.
  • Uses various media forms to maximize communication success.
  • Demonstrates teamwork and the ability to manage time, prioritize, and follow up on projects, including flexibility when working on multiple projects.
  • Participates in meetings with OHRI, PI, and clinical teams to review patient status at a detailed level.
  • Develops strategies and recommends initiatives to meet departmental needs and use resources wisely.
  • Oversees and monitors tasks impacting process or policy changes for the department.
  • Works with research staff to communicate patient processes for each trial throughout the study lifecycle.
  • Advises, communicates, and reinforces standard practices and regulations regarding research study participation.
  • Mentors junior clinical research staff and role models best practices to foster leadership development.
• Other Duties
  • Attends relevant training courses on policy and compliance.
  • Ensures assigned training is completed and meets internal qualifications.
  • Maintains familiarity with evolving regulatory and compliance contexts.
  • Performs other duties as assigned.

Requirements

• Bachelor’s degree from a four-year college or university (required).
• Two years of direct human subjects research experience.
• Two years of direct clinical research experience.

Skills

• Applies critical thinking and creative problem-solving skills across a wide variety of clinical studies.
• Ability to prioritize work across multiple projects.
• Experience working in a team setting.
• Strong verbal and written communication skills, customer service skills, and ability to problem-solve and manage multiple tasks.
• Strong computer skills, including thorough knowledge of EMR and Microsoft systems.

Desired Attributes

• Clinical Research Coordinator Certification (or equivalent approved Clinical Research Certification).
• Three or more years of direct human subjects research experience.
• Clinical knowledge in an assigned therapeutic area or program.