Clinical Research Coordinator Associate

About the Role

The Clinical Research Coordinator Associate is responsible for participating in the day-to-day operations of routine, minimally complex clinical research programs and/or studies. This role performs administrative and operational duties involved in the collection, compilation, documentation, and review of clinical research data, supporting the achievement of research program and/or study objectives. Works under close supervision, receiving instruction, guidance, and direction from senior team members.

Shift: Day Shift, 8:00 a.m. - 4:00 p.m.

Hybrid eligible, depending on business needs.

Key Responsibilities

• Prepares and participates in site initiation, monitoring, closeout visits, document storage activities, and related training.
• Assembles necessary parties to ensure required agreements are in place.
• Utilizes and assists senior team members on electronic data capture systems, technologies, and software for clinical research.
• Scores tests, enters data, and completes required forms accurately and according to protocol.
• Assists with the development of data collection documents and instruments.
• Maintains subject-level documentation.
• Prepares documents, equipment, and/or supplies.
• Identifies issues and recommends solutions.
• Submits assigned studies for review and approval, and provides status updates throughout the startup process.
• Assists the regulatory team with Institutional Review Board (IRB) preparation and submission.
• Screens, schedules, and consents participants.
• With guidance, explains the difference between clinical activities and research activities, and the risks and benefits of study participation.
• Engages with senior study team to maintain participant recruitment and retention rates.
• Assists participants with individual needs.
• Collects information to determine feasibility, recruitment, and retention strategies.
• Collects, prepares, processes, ships, and maintains inventory of research specimens.
• Trains in developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs), and Case Report Forms (CRFs).
• Conducts and documents visits and testing/interviews according to regulatory and organizational protocols.
• Trains in completing and submitting Adverse Event (AE) reports according to institution and sponsor-specific reporting requirements.
• Assists with the development of proposals or protocols as directed.
• Identifies and communicates related shortcomings.
• Maintains appropriate related documentation and tracks Investigational Product (IP) compliance.
• Maintains compliance with institutional requirements and policies.
• Develops and maintains familiarity with the ethical conduct of research and necessary safeguards.
• Trains in the design of safeguards to ensure ethical conduct and protect vulnerable populations.
• Participates in sponsor-required training and professional guidelines and code of ethics training.
• Proactively includes others in decision-making and escalates issues to leadership as necessary.
• Learns various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of research aims.
• Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness.
• Recognizes and reports vulnerabilities related to the security of physical and electronic data.
• Assists with recognizing trends related to data quality and escalates as appropriate.
• Adheres to and participates in the development and assessment of quality assurance.
• Assists with identifying issues related to operational efficiency and shares results with team members.
• Participates in monitoring financial study milestones, corresponding reporting, and ensuring participant care expenses have appropriate financial routing.

Requirements & Tech Stack

• Electronic data capture systems
• Institutional Review Board (IRB) processes
• Standard Operating Procedures (SOPs)
• Case Report Forms (CRFs)
• Adverse Event (AE) reporting
• Investigational Product (IP) compliance
• Ethical conduct of research principles

Qualifications

Minimum Qualifications:

• Degrees: Bachelor of General Studies
• Experience: None
• Licenses & Certifications: None

Additional Qualifications:

• Equivalency: An Associate degree in a related field with five (5) years of clinical-related experience may be considered in lieu of the minimum education requirement.