Job Description

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Comprehensive Research Solutions. LLC (CRS) is seeking a Quality Assurance Specialist (Senior Clinical Research Associate) with an understanding of GCP/ICH and SOPs/Standard Operating Procedures to join our growing team in support of NIH.

Provide assistance in development and implementation of comprehensive Quality Assurance/ Quality Control/ Quality Improvement (QA/QC/QI) Program related processes and procedures ensuring compliance with SOPs, data integrity, and security:

Provide quality oversight of data review in databases. Ensure quality of data generated from clinical sites and assist in resolving data discrepancies

Review and analyze findings (outcome of monitoring/audit and/or quality control (QC) review)

Identify and report trends; suggest quality improvements to ensure high quality of data and clinical research compliance

Perform quality review of clinical database design, functionality, and timeliness to ensure databases are developed in adherence to the protocol requirements, FDA regulations, GCP/ICH, and company SOPs

Identify trends that are attributable to systems and clinical issues. Suggest improvements and assist with implementation of corrective actions

Develop and maintain database of QA/QC findings

Develop and maintain SOPs related to QA/QC and monitoring/audit Program functional areas

Provide orientation and training to Program staff in data quality review and protocol compliance

Serve as liaison and resource for staff

Requirements:

Perform quality review (monitroin/audit/QC) on NIH intramural and extramural multi-institutional research protocols and ensure clinical trials are conducted and data abstracted/recorded/reported in a timely manner Provide quality control of the data in regards of compliance with regulatory requirements on various NIH research protocols Assure adherence to International Commission on Harmonization (ICH), Good Clinical Practices (GCP), and Code of Federal Regulations (CFR). Assure compliance with institutional Standard Operating Procedures (SOPs) and Policies, protocol requirements, and institutional reporting requirements Development of data handling guidelines in order to check validity of clinical data Assure project and study timelines are met Must have a thorough understanding of clinical research protocols, data collection requirements, and methodologies Must be able to recognize clinical values and possess analytical ability to identify data or patient safety issues Must be able to work independently and with others, and lead assigned projects Position involves moderate traveling (relevant to monitoring/audit project only)
REQUIRED EXPERIENCE:

RN, MS or BS/BA in Health or Biological Sciences or another health-related field Minimum of 2 years of medical, clinical, or research related study or instruction. 5 plus years' experience can be substituted for education 2 years of prior monitoring or quality assurance/quality control (QA/QC) experience or equivalent preferred Certifications preferred: ACRP or CCRP certification
PREFERRED QUALIFICATIONS:

RN or MS in health-related field, and 3+ years monitoring experience Experience in oncology clinical research preferred Clinical and/or data management certification (e.g., ACRP, CCRP highly desirable) o Understanding of organs and tissues transplantation processes preferred. Strong communication skills Excellent teamwork
Please be aware that many of our positions require a security clearance, or the ability to obtain one. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information.

CRS is an Equal Opportunity/Affirmative Action Employer. We consider applicants without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, or membership in any other group protected by federal, state or local law.

Please be aware that many of our positions require a security clearance, or the ability to obtain one. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information.

By submitting your resume for this position, you understand and agree that CRS

Corporation may share your resume, as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions.

Job Types: Full-time, Contract

Benefits:

401(k) Dental insurance Flexible schedule Health insurance Paid time off Vision insurance
Work Location: In person