SME II

Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services’ experts create solutions customized to the client’s needs. 

Summary:

The SME II will provide clinical expertise and oversight for the Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS) within the CDC Birth Defects Research and Prevention (CBDRP) program. This role will support the review and classification of complex cardiac and non-cardiac birth defect cases, ensure consistent application of standardized case definitions and classification methodologies, and promote quality and accuracy across clinical reviews.

Key responsibilities include training and supporting clinicians in eligibility reviews and case classification, reviewing complex or discrepant cases, monitoring review progress, overseeing quality control processes, collaborating with data management and CDC staff, and contributing to the development of reporting and data analysis tools. The physician will help ensure consistent classification practices, resolve challenging cases, and maintain the accuracy and integrity of clinical research data.

Essential Job Functions:

• Provide specialized clinical expertise and recommendations to program staff on complex birth defects cases, surveillance findings, classification challenges, and methodological issues to support program objectives and the integrity of birth defects research data.
• Conduct eligibility reviews and classify complex cardiac and non-cardiac birth defect cases for the Birth Defects Study to Evaluate Pregnancy exposures (BD-STEPS) using established case definitions, standardized classification systems, and clinical documentation.
• Train and provide ongoing guidance to CBDRP clinicians on eligibility review procedures, case classification methodologies, and the use of BD-STEPS clinical databases and classification tools. Develop, maintain, and update training materials as needed.
• Provide clinical oversight of quality control processes for cardiac and non-cardiac case reviews and classifications to ensure accuracy, completeness, consistency, and adherence to established protocols.
• Review and reconcile discrepancies, ambiguous findings, and challenging classifications; provide clinical expertise and recommendations to resolve inconsistencies and support accurate case determination.
• Monitor the progress and completion of eligibility reviews and classifications performed by BD-STEPS clinicians, identify issues or delays, and support timely and consistent completion of assigned work.
• Provide enhanced birth defects surveillance and clinical data abstraction to support cluster investigations, special studies, and public health emergency responses.
• Review abstracted cases from birth defects studies and surveillance systems and provide recommendations to program staff regarding the accurate identification and classification of specific birth defects.
• Review data on structural birth defects collected through large, multicenter, multijurisdictional birth defects case-control studies to assess clinical accuracy, completeness, and consistency with established case definitions and classification standards.
• Review birth defects fact sheets, draft guidance documents, and related program materials for clinical accuracy and clarity, and provide recommendations for revisions and improvement.
• Collaborate with the CBDRP lead data manager to review, develop, and refine reports related to eligibility reviews, case classifications, surveillance activities, and quality control processes.
• Assist in the design, development, evaluation, and improvement of data analysis tools and resources that support clinical case review, birth defects classification, surveillance, and research activities.
• Collaborate with CDC staff and CBDRP team members to establish and maintain consistent methodologies for classifying cardiac and non-cardiac birth defects, including ensuring accurate classification of cases involving both types of defects.

Necessary Skills and Knowledge

• Extensive knowledge of congenital birth defects, including structural cardiac and non-cardiac defects, diagnostic criteria, clinical findings, medical terminology, and interpretation of complex medical records.

• Ability to apply standardized case definitions and eligibility criteria, accurately classify birth defects, and support surveillance activities, cluster investigations, special studies, emergency responses, and multicenter research studies.

• Proficiency in reviewing and abstracting clinical information, assessing data accuracy and completeness, identifying discrepancies, reconciling classification differences, and ensuring compliance with established protocols and quality standards.

• Strong analytical and critical-thinking skills to evaluate complex or ambiguous cases, resolve classification challenges, interpret conflicting clinical findings, and provide evidence-based recommendations.

• Ability to train, mentor, and provide clinical guidance to physicians and other staff on eligibility reviews, case classification methodologies, clinical databases, and standardized review procedures.

• Knowledge of birth defects research, epidemiologic methods, case-control studies, public health surveillance systems, and clinical data collection practices.

• Familiarity with clinical research databases, data management systems, reporting processes, and the development and improvement of data analysis tools to support case classification, surveillance, and research activities.

• Ability to review and improve the clinical accuracy, clarity, and consistency of birth defects fact sheets, training materials, technical guidance, reports, and other scientific documents.

• Strong written and verbal communication skills and the ability to collaborate effectively with clinicians, epidemiologists, data managers, researchers, and CDC personnel to ensure consistent classification practices and resolve clinical issues.

• Exceptional attention to detail, organizational and time-management skills, and the ability to manage multiple priorities while maintaining accurate records, protecting confidential health information, and meeting established deadlines.

Minimum Qualifications:

• Medical degree (MD), with relevant clinical experience in pediatrics, pediatric cardiology, clinical genetics, pathology, or a related specialty.

  Experience reviewing and classifying congenital anomalies or birth defects using standardized case definitions.

• Experience with clinical research, birth defects surveillance, epidemiologic studies, or public health programs.

• Experience providing clinical oversight, training, or quality assurance for multidisciplinary clinical review teams.

Preferred Qualifications:

• Board certification in Clinical Genetics, with expertise in dysmorphology, congenital anomalies, genetic syndromes, and phenotypic assessment.

• Extensive experience evaluating complex congenital anomalies, including cardiac and non-cardiac defects, interpreting medical records, applying standardized case definitions, and resolving challenging case classifications.

• Experience in birth defects surveillance, epidemiologic research, clinical case-control studies, or large-scale, multicenter public health research programs, preferably involving CDC or BD-STEPS initiatives.

• Experience overseeing clinical case reviews, ensuring classification accuracy and consistency, resolving discrepancies, and training or mentoring clinicians in standardized review and classification procedures.

• Experience with clinical research databases, data quality and analysis tools, scientific and technical writing, and collaboration with multidisciplinary teams, including clinicians, geneticists, epidemiologists, data managers, and public health professionals.

• Familiarity with CDC birth defects programs, BD-STEPS, and associated clinical databases and classification tools.

   

Pay and Benefits

The salary range for this position is $185.00 to $200.00 per hour.