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.
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.
- 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.
- 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
