Clinical Research & Business Development MGR

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