Clinical Research Associate
- Expired: over a month ago. Applications are no longer accepted.
Job Title: Clinical Research Associate II or III (ACESO)
Location: Bethesda, MD (Candidates will be working Remote 100% but need to be available for East
Coast Work Hours.)
Hours: Full Time, M-F
Type of Hire: Direct Hire
Pay: Salary for Clinical Research II: $75,000- $82,000
Salary for Clinical Research III: $83,000 - $92,000
Our client is seeking a Clinical Research Associate II or III to support the Austere Environments Consortium for Enhanced Sepsis Outcomes (ACESO) located in Bethesda, MD. The client provides scientific, technical, and programmatic support services to ACESO.
ACESO aims to improve survival for patients with sepsis through the development of host-based diagnostic assays and evidence-based clinical management. ACESO is developing host-based diagnostic and prognostic assays for use in low-resource settings to improve survival for patients with sepsis. In addition, ACESO has active observational and clinical trials in six countries and multiple US based locations. This individual is responsible for monitoring the execution of a clinical and IND trial for the ACESO program at both domestic and international clinical research sites.
NOTE: All employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.
1. Ensures that regulatory documents are maintained and are up to date.
2. Ensures that research records and drugs are stored, secured properly, have not expired, are updated and properly maintained
3. Conducts data verification for necessary documents.
4. Ensures that all adverse events have been documented and forwarded to the appropriate principal investigator
5. Assists the investigator and protocol coordinator with questions
6. Ensures that patient transfers are documented along with having the patient vaccine transferred.
7. Reviews Case Report Forms for patient eligibility, protocol compliance, omissions, errors, etc. and files them as required.
8. Reviews the source document files for verification of critical variables, entrance criteria, visit dates, lab data
9. May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.
Required Knowledge, Skills and Abilities:
· Working knowledge of a broad range of medical specialties; working knowledge of all applicable federal and military regulations regarding the use of human and animal subjects in research (e.g.: 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 314,45 CFR 46, FDA Form 1571, and FDA Form 1572). Must be familiar with Institutional Review Board activities and Institutional Biosafety Committee actions. Must be able to set and meet deadlines. Must have recent FDA-regulated drug/vaccine clinical trial monitoring experience. International clinical operations experience preferred.
· Master’s degree in a sciences related field or equivalent required.
Minimum Experience/ Training Requirements:
· A minimum of 3-5 years of experience is required.
Work Environment: Office environment.
Work Arrangement: 100% remote.
Level One Personnel is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other status protected by law
Level One Personnel aggressively recruits, screens and tests applicants to ensure that only qualified candidates are provided to our clients. We pride ourselves on establishing on-going relationships with our candidates and our clients, allowing us to find the best fit for long-term career satisfaction. By matching the right person with the right job, Level One ensures a win-win situation for business clients and employees.
Level One PersonnelWhy Work Here?
We pride ourselves on establishing ongoing relationships with our candidates and our clients.
Level One Personnel combines state-of-the-art staffing expertise and technology with personalized service to our clients. Level One Personnel services range from traditional temporary placement to partnering with companies to help them plan their long-term contingent workforce needs. As a small agency, we are able to focus our attention on our client’s specific needs and provide the absolute best candidates and customer service available in the industry. Level One Personnel aggressively recruits, screens and tests applicants to ensure that only qualified candidates are provided to our clients. We pride ourselves on establishing on-going relationships with our candidates and our clients, allowing us to find the best fit for long-term career satisfaction. By matching the right person with the right job, Level One ensures a win-win situation for business clients and employees.