Clinical Research Sub-Investigator and Compliance Manager

Clinical Study Analysis and Compliance Manager

Kelly Science and Clinical is currently hiring a permanent Clinical Study Analysis and Compliance Manager / Sub-I for one of our clients who supports biotechnology companies accelerate the creation of life-saving health screening solutions.

We are seeking a motivated and detail-oriented team member to join their dynamic team and contribute to groundbreaking research studies and trials.

Job Title : Clinical Study Analysis and Compliance Manager

Location : Kansas City, MO

Job Type : Full-time

Pay Rate : Competitive salary based on experience

Shift : Onsite presence required

Job Summary :

We are seeking a highly skilled and motivated Clinical Study Analysis and Compliance Manager to join our client, a technology and service company focused on developing early detection screening technologies for cancer and other diseases.

In this role, you will lead a team of research analysts, oversee site initiation, and ensure compliance with all regulatory requirements for clinical studies.

Additionally, you will serve as a sub-investigator, playing a direct role in clinical trials. This is a direct hire position based in Kansas City, MO, and requires onsite presence.

The ideal candidate will hold a medical degree (e.g., RN, NP, MD) with experience in clinical research.

Roles and Responsibilities :

• Lead and manage a team of research analysts, ensuring accurate and timely data collection and regulatory compliance.
• Own and manage regulatory study data, ensuring accuracy, completeness, and adherence to compliance standards.
• Serve as a sub-investigator in clinical trials, contributing to study design, patient oversight, and data analysis.
• Validate incoming clinical study data for regulatory compliance purposes.
• Input and manage downstream data activities within the Electronic Data Capture (EDC) system.
• Oversee the creation and updating of regulatory binders, ensuring all documentation meets regulatory and study requirements.
• Collaborate with cross-functional teams, including clinical sites and providers, to maintain compliance and support study execution.
• Assist in the preparation and submission of regulatory documents for clinical trials and audits.
• Stay current with clinical research regulatory guidelines and best practices to ensure adherence to industry standards.
• Provide training and guidance to the research team on regulatory compliance and clinical study processes.

Qualifications & Skills :

• Medical degree required (e.g., Registered Nurse (RN), Nurse Practitioner (NP), Doctor of Medicine (MD), or similar).
• Strong experience and knowledge in clinical research, including serving as a sub-investigator in clinical studies.
• Proficiency in Electronic Medical Records (EMR) systems and Electronic Data Capture (EDC) systems.
• Understanding of ICD-10 coding and familiarity with medications and their classifications.
• Previous experience in leading and managing a team, preferably in a clinical research setting.
• Familiarity with medical billing and coding preferred but not required.
• Excellent attention to detail, organizational, and analytical skills.
• Strong communication and leadership abilities to effectively manage teams and collaborate with stakeholders.
• Ability to work both independently and as part of a cross-functional team.

Note : A clinical medical degree and relevant certifications may be required for this position.