SME II

Goldbelt, Inc.•De Leon Springs, FL

About The Position

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. The role supports the review and classification of complex cardiac and non-cardiac birth defect cases, consistent use of standardized case definitions and classification methodologies, and quality and accuracy across clinical reviews. The physician will train and support clinicians in eligibility reviews and case classification, review complex or discrepant cases, monitor review progress, oversee quality control, collaborate with data management and CDC staff, and contribute to reporting and data analysis tools. The role also supports enhanced birth defects surveillance, cluster investigations, special studies, and public health emergency responses, while helping maintain the accuracy and integrity of clinical research data.

Requirements

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.
Extensive knowledge of congenital birth defects, including structural cardiac and non-cardiac defects, diagnostic criteria, clinical findings, medical terminology, and complex medical records.
Ability to apply standardized case definitions and eligibility criteria, classify birth defects, and support surveillance, investigations, studies, emergency responses, and multicenter research.
Proficiency in reviewing and abstracting clinical information, assessing accuracy and completeness, identifying discrepancies, reconciling classification differences, and following protocols and quality standards.
Strong analytical and critical-thinking skills to evaluate complex or ambiguous cases, interpret conflicting clinical findings, and provide evidence-based recommendations.
Ability to train, mentor, and provide clinical guidance to physicians and other staff on reviews, classification methodologies, databases, and standardized 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 data analysis tools.
Ability to review and improve the clinical accuracy, clarity, and consistency of fact sheets, training materials, technical guidance, reports, and scientific documents.
Strong written and verbal communication skills and ability to collaborate with clinicians, epidemiologists, data managers, researchers, and CDC personnel.
Attention to detail, organizational and time-management skills, and ability to manage multiple priorities, maintain accurate records, protect confidential health information, and meet deadlines.

Nice To Haves

Board certification in Clinical Genetics, with expertise in dysmorphology, congenital anomalies, genetic syndromes, and phenotypic assessment.
Extensive experience evaluating complex congenital anomalies, interpreting medical records, applying standardized case definitions, and resolving challenging 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.
Experience with clinical research databases, data quality and analysis tools, scientific and technical writing, and multidisciplinary collaboration.
Familiarity with CDC birth defects programs, BD-STEPS, and associated clinical databases and classification tools.

Responsibilities

Provide specialized clinical expertise and recommendations on complex birth defect cases, surveillance findings, classification challenges, and methodological issues.
Conduct eligibility reviews and classify complex cardiac and non-cardiac birth defect cases for BD-STEPS using established case definitions, standardized classification systems, and clinical documentation.
Train and provide ongoing guidance to CBDRP clinicians on eligibility reviews, classification methodologies, clinical databases, and classification tools; develop and maintain training materials.
Provide clinical oversight of quality control for cardiac and non-cardiac case reviews and classifications.
Review and reconcile discrepancies, ambiguous findings, and challenging classifications, providing recommendations to support accurate case determination.
Monitor the progress and completion of clinicians’ eligibility reviews and classifications, identify issues or delays, and support timely completion.
Provide enhanced birth defects surveillance and clinical data abstraction for cluster investigations, special studies, and public health emergency responses.
Review abstracted cases from birth defects studies and surveillance systems and recommend accurate identification and classification of specific birth defects.
Review structural birth defect data from large, multicenter, multijurisdictional case-control studies for clinical accuracy, completeness, and consistency with established standards.
Review birth defects fact sheets, draft guidance, and related program materials for clinical accuracy and clarity, and recommend improvements.
Collaborate with the CBDRP lead data manager to review, develop, and refine reports related to eligibility reviews, classifications, surveillance, and quality control.
Assist in designing, developing, evaluating, and improving data analysis tools and resources for clinical case review, classification, surveillance, and research.
Collaborate with CDC staff and CBDRP team members to establish and maintain consistent classification methodologies for cardiac and non-cardiac birth defects, including cases involving both.