What are the responsibilities and job description for the Clinical Data Assistant - NIH position at Global Solutions Network Inc?
Global Solutions Network (GSN), a federal government contracting firm, presents this full time, long-term position supporting GSN's customer at the National Institutes of Health (NIH), Clinical Center. This position provides a competitive salary and comprehensive benefits.
If interested, please provide an up-to-date resume.
Responsibilities.
- Retrieve research related information from medical records, hospital information systemCRIS andor laboratory information system LIS; create spreadsheets and other reports for use in study analysis
- Keeping update and maintain a comprehensive database for tracking specimens and associated data 1
- Perform regular audits of the database to ensure data integrity 2
- Stay updated with emerging technologies and recommend improvement 3
- Assist researchers coordinate, facilitate and prepare site for monitoring visits and FDA audits 5
- Assist preparing and submitting for review accurate source documents related to all research procedures. 4
- Create data visualizations and summaries for various stakeholders
- Set up, format and enter data into spreadsheets to analyze information and create reports.
- Enter data into research databases, systems and applications for ongoing studies.
- Verify study participant information and collect data and results of testing.
- Enter data into research databases systems and applications for ongoing studies
- Assist researchers develop, maintain and complete study data collection forms and source documents.
- Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations and meeting minutes/summaries.
- Review draft protocols, case report forms, and manuals of operations for clarity, and completeness.
- Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis.
- Assist researchers with the collection and analysis of research data and samples.
- Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events.
- Assist key research personnel ensure that clinical research activities are performed in accordance with federal, state and institutional regulations, policies and procedures.
- Assist researchers develop and maintain current and new research protocols.
- Work with investigators to assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system.
- Support the clinical studies managing the collection and storage of human specimens
- Maintain specimen inventory and assist with specimen requests
- Implement procedures for specimen quality monitoring and assurance
- Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry.
- Assist researchers coordinate, facilitate and prepare site for monitoring visits and FDA audits.
- Coordinate with researchers, clinicians, and other stakeholders to facilitate specimen use and data access
- Assist with the update standard operating procedures (SOPs) for specimen and data management
- Assist issues related to specimen and data handling
- Assist researchers with study testing, observations data entry and other duties associated with study sessions.
Qualifications.
- Bachelor's degree in a related field preferred
- Associates degree acceptable with appropriate years of equivalent experience.
- Proficient in MS Office Suite (including Teams)
- Strong Oral and written communication skills
- Analytical, organizational and time management skills
Benefits.
- Medical, Dental, & Vision Coverage
- Paid Time Off and Paid Holidays
- 401K/Profit Sharing Plan
- Flexible Spending Accounts (Healthcare & Dependent Care)
- Pretax Parking & Transportation Plan
- Short-Term & Long-Term Disability Insurance
- Life & AD&D Insurance
- Professional Development/Education
- Employee Referral Bonuses
- Employee Discount Program
- Merit Bonuses
- Employee Assistance Program
- Travel Assistance Program
Global Solutions Network, Inc. (GSN) is an Equal Employment Opportunity (EEO) employer. It is the policy of the GSN to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected US veteran or disabled status, or genetic information.