Clinical Research Associate

Position Title: Clinical Research Associate

Location: Bethesda, MD

We are seeking a Clinical Research Associate in Bethesda, MD to support our NIH customer.

JOB DESCRIPTION:

Comprehensive Research Solutions Company is seeking a Clinical Research Associate who’ll be responsible for the monitoring of single site and multi-site clinical research trials. Knowledge of medical terminology is mandatory. You’ll be expected to expand knowledge base and be able to apply relevant Good Clinical Practices (GCP), International Commission on Harmonization (ICH), and regulatory guidelines and procedures to assigned tasks. Performance of this position requires coordination and interaction among various research teams and team members.

This position will be responsible for the following:

• Monitor NIH intramural and extramural multi-institutional research protocols and ensure clinical trials are conducted 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.
• Position involves moderate traveling

REQUIRED EXPERIENCE:

• RN, MS or BS/BA in Health or Biological Sciences or another health-related field
• Minimum of 1 years of medical, clinical, or research related study or instruction. 3 plus years’ experience can be substituted for education
• 1 years of prior monitoring 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. o Strong communication skills

o 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 résumé for this position, you understand and agree that CRS
Corporation may share your résumé, 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)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Work Location: One location