Clinical Data Abstractor Jobs

Minimum 3-5 years of experience in a pharmaceutical/CRO setting with at least 3-4 years of experience in Data Management.

Liaise closely with the Lead Data Manager to report study progress and any issues outstanding.

Assist the Lead Data Manager with the preparation of study documentation.

Assist the Lead Data Manager with the creation and validation of Manual and SAS checks.

Proficient knowledge of CDISC CDASH and SDTM terminology

Attend study update meetings or calls with the study sponsor as needed.

Maintains patient tracking spreadsheets to ensure data entry requirements are met.

Responsible for prompt and accurate data entry for protocols, including Serious Adverse Events.

FULLY REMOTE | CLINICAL DATA COORDINATOR | EAST COAST | APPLY TODAY

Assists in the coordination of initiation, site evaluation, monitoring visits, and audits required by the sponsor.

Works with research team in managing the visits of active and follow up subjects on research protocols.

Processes study specific data collection documents into case report forms.

Previous project management, quality improvement methodology, and/or healthcare informatics experience preferred

Previous experience with quality measure analysis, reporting and regulatory requirements

2 or more years of acute clinical care experience in a hospital setting

Ability to analyze and interpret complex data, measure specifications, and regulatory requirements

Critical thinking, analysis, and research skills

CPHQ (Certified Professional in Healthcare Quality) certification preferred

Proven experience with research as well as knowledge of best practices for HIPAA, consent, GCP, FDA, SOP, safety monitoring, and others.

Competitive wage plus great benefits - medical/dental/vision, 401(k) match, etc.

Ensure compliance, create reports, and prepare for sponsor and regulatory manager visits.

Bachelor’s degree in related science field or equivalent amount of clinical research experience in the given study area.

CCRA, CCDM, CCRC, or CCRP certification required.

Strong communication skills and ability to collaborate with a team.

Skillful with written and oral skills for communicating performance considerations and improvement opportunities to correct parties. Report findings/opportunities/trends to management levels.

Bachelor's degree or equivalent education and experience

Able to complete certifications (pass exams) if assigned to an abstraction that requires it.

One year experience in a healthcare related field

Supports collaboration with internal team members and external vendors to ensure inter-rater reliability as well as data accuracy and timely submission.

Contribute to specialized committee or work group meetings in support of process improvements to enhance patient outcomes.

Previous project management, quality improvement methodology, and/or healthcare informatics experience preferred

Previous experience with quality measure analysis, reporting and regulatory requirements

2 or more years of acute clinical care experience in a hospital setting

Ability to analyze and interpret complex data, measure specifications, and regulatory requirements

Critical thinking, analysis, and research skills

CPHQ (Certified Professional in Healthcare Quality) certification preferred

- Exp with Clinical research trial documentation and clinical data management.

- Experience with clinical research trials in med devices.

- Experience using any kind of online eTMF(Electronic Trial Master File).

- Working knowledge of Microsoft office tools - Excel, word, outlook.

- Knowledge knowledge on using statistics.

- SAS experience is nice to have (running the program).

Pharmacy technician certification plus 2 years related work experience, or 4 years related work experience.

Demonstrated ability to effectively communicate with management and other team members

Demonstrated ability to apply pharmacy knowledge and experience in critical thinking and problem solving; ability to recognize discrepancies in data

Perform data normalization prior to data entry, using controlled terminology and following strict editorial guidelines

Strong computer skills; familiarity with Microsoft Office products (e.g., Word, Excel, Access) and Adobe Professional

Solid knowledge of internet searching and pharmaceutical terminology

Primary Duties and Responsibilities include the following:

4. Develop, institute and manage initiatives and strategic plans in response to trending data

7. Manage employee and departmental timeliness and progress during development and implementation of new initiatives

8. Measure and manage staff compliance with new processes and overall success of programs

12. Maintain clinical department files for staff credentialing, licensure and education

14. Manage departmental schedules and communications

Communicate with Carta team and reporting hospitals to streamline data management

2+ years direct GWTG Registry Abstraction experience for a Health System or Hospital

Current abstracting experience. Actively abstracting within the past 12 months

Knowledge of basic medical terminology, proficiency in EMR, and exposure to a healthcare environment is appropriate.

Remote training and onboarding compatible

Provide data analysis to reporting hospital managers, as appropriate

Experience and knowledge of several medical registries with relevant clinical background

Communicate with Carta team and reporting hospitals to streamline data management

2+ years direct TVT / LAAO Registry Abstraction experience for a Health System or Hospital

Current abstracting experience. Actively abstracting within the past 12 months

Knowledge of basic medical terminology, proficiency in EMR, and exposure to a healthcare environment is appropriate.

Remote training and onboarding compatible

Ensures data management activities are conducted in accordance with ICH/GCP, internal SOPs and Work Instructions, and meet all regulatory requirements

Clinical Data Management 3+ years’ experience across Phase 1-4 clinical trials

Creates and maintains project documentation, including, but not limited to, Data Management Plan, CRF Completion Guidelines and validation specifications

Prepares and distributes project status reports to project team and management

Prepares and reports query trends and data/query/CRF completion/missing pages/SDV metrics to the Study Management Team (SMT)

Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology

1‐3 years in Health Information Management; Coding, Nursing, and/or Health Registry abstraction experience

Education assistance (tuition, student loan, certification support, dependent scholarships)

Family support through fertility and family building benefits with Progyny and adoption assistance.

Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.

Maintain clinical knowledge of various abstracted measures.

Communicate in a timely manner with manager to achieve measure compliance.

Education assistance (tuition, student loan, certification support, dependent scholarships)

Family support through fertility and family building benefits with Progyny and adoption assistance.

Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.

Learn More About Employee Benefits

Note: Eligibility for benefits may vary by location.

Free counseling services and resources for emotional, physical and financial wellbeing

One (1) year (12 months) of data management/analyst work experience in a clinical or healthcare related field.

Project management and time management skills

Highly prefer previous experience as a Registered Nurse with strong clinical workflow knowledge

Knowledge of common computer skills including Word, Excel, and PowerPoint

Participates in education/training of individuals or teams on data analysis and interpretation.

Is able to participate in programmatic improvements by demonstrating an understanding of clinical workflows and holistic patient experience.

Assist in user-acceptance testing of the abstraction guidelines, workflows, education materials, data entry, etc.

Maintain current knowledge of project requirements related to clinical data abstraction

Preferred Skills:Preferred oncology expert level knowledge

Responsibilities :Role will be responsible for interpreting and organizing clinical data through the execution of medical chart abstraction.

Provide input and recommendations to improve the overall abstraction process (abstraction guidelines, educational resources, clinical insight, abstraction workflow input)

Track completion of assigned work and report status as requirements

- Bachelor's degree or associate degree OR 2 or more years of applicable professional experience

- Intermediate to advanced Excel skills -- specifically, sorting and filtering

6 month contract w potential to extend/convert

- Technical aptitude; ability to learn new technologies and processes quickly

- Affinity for data; enjoy working within a data-intensive environment

- Strong attention to detail

Required Knowledge, Skills, and Abilities (Proficiencies):

Required Experience, Education, Certification(s), License(s)

Preferred Experience, Education, Degree, Certification(s), License(s)

Associate Degree or BS in Health Information Management, Nursing or related field, preferred.

Extensive knowledge of medical terminology, human anatomy and physiology, and clinical disease process required.

Previous work experience in medical record abstraction activities preferred.

Assists the Department Manager or others in recognizing and reducing risk within the Department or other areas of the Hospital

Prior experience in chart review and data abstraction

3 years clinical cardiovascular experience (preferred)

All the benefits and perks you need for you and your family:

Paid Days Off from Day One

AdventHealth Pepin Heart Institute, known across the country for its advances in cardiovascular disease prevention, diagnosis, treatment and research.

With oversight from Lead Data Manager, issue and manage queries in the EDC database

Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.

Review protocols and apply protocol-specified guidelines to the structure, review, and cleaning of clinical data

Support study set-up, including EDC build (forms, edit checks, and study structure) and validation UAT testing

Build EDC forms from protocol or source document specifications

Build/program EDC edit checks from specification documents