[Hiring] SME II @Goldbelt, Inc.

Role Description

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.

• Provide specialized clinical expertise and recommendations to program staff on complex birth defects cases, surveillance findings, classification challenges, and methodological issues.
• Conduct eligibility reviews and classify complex cardiac and non-cardiac birth defect cases using established case definitions and standardized classification systems.
• Train and provide ongoing guidance to CBDRP clinicians on eligibility review procedures, case classification methodologies, and the use of BD-STEPS clinical databases.
• Develop, maintain, and update training materials as needed.
• Provide clinical oversight of quality control processes for case reviews and classifications.
• Review and reconcile discrepancies, ambiguous findings, and challenging classifications.
• Monitor the progress and completion of eligibility reviews and classifications performed by BD-STEPS clinicians.
• Provide enhanced birth defects surveillance and clinical data abstraction to support investigations and public health emergency responses.
• Review abstracted cases from birth defects studies and provide recommendations for accurate identification and classification.
• Review data on structural birth defects collected through large, multicenter studies to assess clinical accuracy and consistency.
• Review birth defects fact sheets and draft guidance documents for clinical accuracy and clarity.
• Collaborate with the CBDRP lead data manager to review and refine reports related to eligibility reviews and quality control processes.
• Assist in the design, development, evaluation, and improvement of data analysis tools.
• Collaborate with CDC staff and CBDRP team members to establish consistent methodologies for classifying birth defects.

Qualifications

• Extensive knowledge of congenital birth defects, including structural cardiac and non-cardiac defects.
• Ability to apply standardized case definitions and eligibility criteria accurately.
• Proficiency in reviewing and abstracting clinical information and assessing data accuracy.
• Strong analytical and critical-thinking skills to evaluate complex cases.
• Ability to train, mentor, and provide clinical guidance to staff.
• Knowledge of birth defects research, epidemiologic methods, and clinical data collection practices.
• Familiarity with clinical research databases and data management systems.
• Ability to review and improve the clinical accuracy of scientific documents.
• Strong written and verbal communication skills.
• Exceptional attention to detail and organizational skills.

Requirements

• Medical degree (MD) with relevant clinical experience in pediatrics or related specialty.
• Experience reviewing and classifying congenital anomalies using standardized case definitions.
• Experience with clinical research, birth defects surveillance, or public health programs.
• Experience providing clinical oversight, training, or quality assurance for clinical review teams.

Preferred Qualifications

• Board certification in Clinical Genetics with expertise in dysmorphology and congenital anomalies.
• Extensive experience evaluating complex congenital anomalies and resolving challenging case classifications.
• Experience in birth defects surveillance and epidemiologic research.
• Experience overseeing clinical case reviews and training clinicians in standardized procedures.
• Familiarity with CDC birth defects programs and associated clinical databases.

Pay and Benefits

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