Top 12 Clinical documentation specialist Jobs in Frederick Md

Clinical Lab Information Specialist
Precision for Medicine —Frederick, MD
- $83,200 - $124,800 a year
- Online Application
- 5 years
- Master's degree
- Bachelor's degree
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Clinical Lab Information Specialist
Precision Medicine Group —Frederick, MD
- $83,200 - $124,800 a year
- Online Application
- 5 years
- Master's degree
- Bachelor's degree
Manager, Clinical Documentation Integrity
Adventist HealthCare —Gaithersburg, MD
- $105,664.42 - $158,496.00 a year
- Full-time
- Medicine
- Anatomy knowledge
- RN License
- Free parking
- AD&D insurance
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Clinical Documentation Integrity (CDI) Specialist
Meritus Medical Center Inc —Hagerstown, MD
- $74,692.80 - $112,091.20 a year
- Nursing
- Microsoft Excel
- RN License
- Disability insurance
- Health insurance
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Inpatient Coder - Full-time with Benefits
Frederick Health —Frederick, MD
- $26.46 - $37.80 an hour
- Overtime
- Anatomy knowledge
- Surgery
- 5 years
- Disability insurance
- Health insurance
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Tumor Registry Specialist
Meritus Medical Center Inc —Hagerstown, MD
- $20 - $30 an hour
- Part-time
- Nursing
- Anatomy knowledge
- Mid-level
- Health savings account
- Disability insurance
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Outpatient Ancillary Coding Specialist
Meritus Medical Center Inc —Hagerstown, MD
- $20.77 - $31.15 an hour
- Full-time
- Remote
- Mid-level
- 1 year
- Associate's degree
- Disability insurance
- Health insurance
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Medical Scribe
Scribe.ology —Frederick, MD
- $17.65 - $18.00 an hour
- Part-time
- Urgent Care
- No experience needed
- Clinic
- Health insurance
- Paid time off
Coder - Same Day Surgery - Full-time with Benefits
Frederick Health —Frederick, MD
- $20.84 - $30.68 an hour
- Overtime
- Surgery
- Mid-level
- High school diploma or GED
- Disability insurance
- Health insurance
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Travel IMC RN Job in Birmingham, Alabama
GIFTED Healthcare —United States
- $2,122.06 a week
- Overtime
- Nursing
- Medication administration
- RN License
- Health insurance
- Dental insurance
Quick Apply

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Clinical Lab Information Specialist

Precision for Medicine -
Frederick, MD

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Job Details

$83,200 - $124,800 a year

Qualifications

CAP guidelines
FDA 21 CFR Part 11
Clinical laboratory experience
User acceptance testing
CLIA regulations
Biomedical regulatory compliance
Clinical quality assurance standards
Laboratory information systems (LIS)
Middleware systems
Stakeholder management

Full Job Description

Job Summary:

The Clinical Lab Information Specialist plays a critical role in supporting laboratory technology initiatives with a strong emphasis on User Acceptance Testing (UAT), system validations, and regulatory compliance documentation. This position serves as a key liaison between laboratory operations, IT, quality, and external vendors to ensure that laboratory systems are implemented, validated, and maintained in accordance with regulatory standards and business needs. This position is fully onsite at our Frederick, MD location.

The ideal candidate combines deep clinical laboratory knowledge with expertise in system implementation, validation methodologies, and regulatory documentation within a highly controlled environment (e.g., CLIA, CAP, FDA, GxP).

Main Duties & Responsibilities:

Essential duties include but are not limited to:

UAT Leadership & Execution

Lead and coordinate User Acceptance Testing (UAT) activities for laboratory information systems (LIS), middleware, instrumentation interfaces, and other clinical lab technologies
Develop UAT strategies, test plans, scripts, and acceptance criteria aligned with business and regulatory requirements
Partner with laboratory stakeholders to ensure test scenarios reflect real-world workflows and operational use cases
Facilitate defect tracking, triage, and resolution in collaboration with IT and vendors
Ensure traceability between requirements, test cases, and outcomes

System Validation & Compliance

Plan and execute system validation activities in accordance with regulatory standards (e.g., GxP, FDA 21 CFR Part 11, CLIA, CAP)
Author and/or review validation deliverables, including:
- Validation Plans (VP)
- Requirements Specifications (URS/FRS)
- Risk Assessments
- IQ/OQ/PQ protocols and reports
- Traceability matrices
Ensure systems are audit-ready and compliant with internal quality systems and external regulatory expectations
Support audit and inspection activities, including responses and corrective actions

Regulatory Documentation & Quality Support

Develop and maintain SOPs, work instructions, and supporting documentation related to laboratory systems and processes
Ensure documentation aligns with quality management system (QMS) requirements
Collaborate with Quality Assurance to maintain compliance and support continuous improvement initiatives
Maintain document control and versioning in accordance with regulatory standards

Business Analysis & Stakeholder Engagement

Gather, analyze, and document business and functional requirements from laboratory stakeholders
Translate complex laboratory workflows into system requirements and technical specifications
Serve as a liaison between laboratory operations, IT, vendors, and quality teams
Facilitate workshops, meetings, and process mapping sessions

System Implementation & Optimization

Support system implementation, upgrades, and enhancements across laboratory platforms
Identify opportunities to improve efficiency, data integrity, and compliance through system optimization
Provide subject matter expertise on laboratory processes, informatics, and regulatory expectations

Education & Experience:

Minimum Education & Experience:

Bachelor's Degree or Master Degree in Clinical Laboratory Science, Life Sciences, Health Informatics, or related field required
5-8 years of related experience in clinical laboratory operations, laboratory informatics, or business analysis
Strong experience with laboratory systems (LIS, LIMS, middleware, instrument interfaces)
Demonstrated expertise in UAT coordination and execution
Hands-on experience with system validation in regulated environments (GxP, CLIA, CAP, FDA)
Experience authoring validation and regulatory documentation

Preferred Education & Experience (optional):

Experience with specific LIS platforms (e.g., Epic Beaker, SCC Soft, Sunquest, Cerner Millennium)
Familiarity with data standards (HL7, interfaces, instrument connectivity)
Experience in audit/inspection readiness and regulatory submissions
Knowledge of electronic document management systems (eDMS) and change control processes

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [email protected] so we can investigate and take appropriate action.

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Refine Your Search

clinical documentation specialist jobs in frederick md

Clinical Lab Information Specialist

Clinical Lab Information Specialist

Manager, Clinical Documentation Integrity

Clinical Documentation Integrity (CDI) Specialist

Inpatient Coder - Full-time with Benefits

Tumor Registry Specialist

Outpatient Ancillary Coding Specialist

Medical Scribe

Coder - Same Day Surgery - Full-time with Benefits

Travel IMC RN Job in Birmingham, Alabama

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