KCC is seeking an entrepreneurial and highly motivated Clinical Research & Business Development Manager to help build and scale a premier nephrology-focused clinical research platform. This individual will play a dual role: coordinating and executing clinical trials while simultaneously driving business development efforts to expand KCC Research's study portfolio, sponsor relationships, and research footprint.

This position is ideal for a candidate who understands both the operational requirements of clinical research and the strategic growth initiatives required to build a successful research organization.

PRIMARY DUTIES / ACTIVITIES:

Clinical Research Operations
• Coordinate all aspects of clinical trial execution from study startup through closeout.
• Conduct patient screening, recruitment, enrollment, scheduling, and retention activities.
• Ensure protocol compliance, source documentation accuracy, and regulatory adherence.
• Maintain study binders, regulatory documents, and investigator site files.
• Coordinate sponsor visits, monitoring visits, audits, and site inspections.
• Manage study budgets, patient reimbursement tracking, and study milestones.
• Collaborate with physicians, nurses, and staff to ensure seamless study execution.
• Track enrollment metrics and proactively identify barriers to recruitment.

Business Development & Growth
• Identify and pursue new clinical trial opportunities with sponsors, CROs, SMOs, and biotechnology companies.
• Develop and maintain relationships with sponsors and research partners.
• Participate in feasibility assessments and site qualification questionnaires.
• Represent KCC Research during sponsor meetings and industry conferences.
• Assist in contract and budget negotiations with sponsors.
• Create presentations and marketing materials highlighting KCC's research capabilities.
• Build and maintain a pipeline of future study opportunities.

Patient Identification & Recruitment Strategy
• Develop disease-specific patient registries across KCC.
• Utilize ECW and other data tools to identify eligible study candidates.
• Analyze patient populations across multiple states and practices to support feasibility assessments.
• Work with physicians to identify and refer potentially eligible patients.
• Develop recruitment campaigns for rare kidney diseases including IgA Nephropathy, FSGS, Lupus Nephritis, ADPKD, CKD, and other nephrology-focused conditions.

Data & Strategic Initiatives
• Support the development of a KCC-wide research database and disease registry.
• Generate enrollment forecasts and sponsor-facing feasibility reports.
• Analyze patient populations using ICD-10-based searches and EMR reporting tools.
• Track research performance metrics and develop executive reporting dashboards.
• Assist leadership in identifying strategic growth opportunities for KCC Research.

EDUCATION/ QUALIFICATIONS:
• Bachelor's degree in Life Sciences, Healthcare Administration, Public Health, Nursing, or related field.
• CCRP, CCRC, or SOCRA certification preferred.
• Strong understanding of GCP, ICH guidelines, FDA regulations, and IRB processes.
• Excellent communication and relationship-building skills.
• Strong organizational and project management abilities.

EXPERIENCE:
• Minimum 3 years of clinical research experience, preferably in an industry-sponsored setting.
• Experience in nephrology, internal medicine, or chronic disease research.
• Familiarity with ECW, EMRs, and patient registry development.
• Experience working with CROs, SMOs, and pharmaceutical sponsors.
• Experience coordinating industry-sponsored clinical trials.
• Experience in nephrology, internal medicine, or chronic disease research.
• Experience with sponsor outreach, business development, or study feasibility.
• Budget and contract negotiation experience.
• Must be PC proficient and able to thrive in a fast-paced setting; experience in Microsoft Office Suite: Outlook, Word and Excel a must.
• Good presentation & communication skills.

Compensation:

Competitive base salary plus performance-based incentives tied to:
• Study startup and activation
• Patient enrollment targets
• Sponsor acquisition
• New study opportunities secured
• Overall growth of KCC Research