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Job Description
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
