Job Description

Job Description

About Us

We are a fast-growing, PE-backed Site Management Organization (SMO) dedicated to building a national platform of leading clinical research sites. Our mission is to help our physician partners thrive in private practice while accelerating innovation in clinical trials and providing access to cutting-edge therapies for patients.

Position Overview

We are looking for a Lead Clinical Research Coordinator (CRC) to help us set up a clinical research program for a large urology practice in the Sioux Falls area. The CRC works directly under the supervision of the Principal Investigator (PI) to manage all aspects of clinical trial activities. The CRC is essential in facilitating and coordinating daily clinical trial activities, ensuring compliance, quality, and efficiency throughout the trial process. This role involves direct collaboration with the PI, sponsors, and other key stakeholders. The CRC will interact with patients during the recruitment and screening process. The CRC will also facilitate the informed consent process and provide ongoing participant support as needed.

Key Responsibilities

• Regulatory and Institutional Compliance: Support the Principal Investigator and relevant departments to ensure all clinical research activities comply with federal regulations, institutional policies, and sponsor requirements.
• Documentation Management: Maintain secure and accurate storage of all study documents, including consent forms, case report forms, and investigational material records, in compliance with both sponsor and institutional requirements.
• Study Oversight: Support the PI in ensuring the study meets compliance standards, including Institutional Review Board (IRB) approvals, health and safety requirements, conflict of interest disclosures, and adherence to financial terms.
• Stakeholder Coordination: Maintain regular and effective communication with Sponsors, Contract Research Organizations (CROs), and internal team members (e.g., Investigators, Nurses, Medical Assistants) to facilitate study progress.
• Meeting Participation: Engage in Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and other key study meetings as required.
• Problem-Solving and Adaptation: Identify and anticipate potential obstacles to study timelines or deliverables, offering creative solutions to maintain momentum and study integrity.
• Inventory and Equipment Management: Manage study-specific inventory, including identification, ordering, calibration, and secure storage of equipment required for the study.

Qualifications

• Minimum of five years of Clinical Research Coordinator experience.
• Experience with various Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and electronic Trial Master File (eTMF) systems.
• Comprehensive understanding of urology, oncology, and other associated therapeutic areas, medical terminology, to effectively execute clinical trials.
• Deep knowledge of ICH-GCP, and regulatory requirements, with the ability to implement these effectively throughout the clinical trial.
• Experience with data management processes, ensuring the accuracy and completeness of data collection, entry, and reporting, in line with Good Clinical Data Management Practices (GCDMP).
• Experience ensuring and prioritizing patient safety and data integrity, embodying a commitment to the ethical conduct of clinical trials.
• Experience maintaining the highest quality standards, while focusing on ongoing process improvements that lead to enhanced clinical trial efficiency and compliance.
• Excellent interpersonal communication, both written and verbal. Can easily interface with team members and external stakeholders. Proven ability to develop positive relationships with internal teams, physicians, and external partners.
• Strong attention to detail, and ability to handle multiple tasks simultaneously in a dynamic research environment.
• Strong computer skills (MS Office, M PowerPoint, etc.) and software experience (CTMS, eTMF, EDC, IXRS, RTSM, etc.)
• Ability to prioritize tasks, effectively manage time, and allocate resources efficiently to meet tight study deadlines.
• Bachelor's degree or equivalent combination of education/experience in science or health-related field.
• Any data provided as a part of this application will be stored in accordance with our Policy.

Salary Range: Competitive with bonus potential

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