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CRA III +

System One
Bethesda, MD
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Clinical Research Associate Level III or Senior CRA
Direct Hire
Location: Remote
 

Notes:

  1. What are the absolute hard skills required for this position: 
    • Interventional trial experience in the very recent past if not current
    • Has to understand FDA regulatory trials.
    • Lead CRA on the study. Someone who is experienced and works well in as a team lead. Doesn't need much of mentorship guidance. Very confident in leading 
  2. RX area is Sepsis (systemic  inflammatory syndrome may progress to severe sepsis or septic shock) - helpful but not required
  3. Has to be available for Core hours 9-3:30 pm and flexible with how early you want to begin your day
  4. If you are not in the DMV area, would need to travel to DMV home office 1-2 times annually. Travel paid/reimbursed. 
  5. 100% remote but would prefer East Coast due to time meeting of the calls.

JOB DESCRIPTION:
We are seeking a Clinical Research Associate to monitor the execution of clinical trials associated with specific projects and ensure that all necessary steps are taken towards safety provisions and all regulations are adhered to.

 Responsibilities

  • Submits protocol application and consent forms on behalf of PI to local Institutional Review Board (IRB). Ensures that all amendments, continuing reviews and adverse events have been submitted to the IRB. Acting on behalf of the Principle Investigator (PI) holds the highest level of importance. This role requires editing, reviewing and interaction with multiple levels of review committees.
  • Assures sufficient investigator qualifications, training, facility resources, laboratories, equipment, and staff to properly support studies. Ensures the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness. Monitors and assesses the clinical research site's patient recruitment and retention success. Develops and maintains study manuals, standard operating procedures, study specific procedures and protocol training in conjunction with the PI, study team and CRO.
  • As per Executive Order 14042, all HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.
  • Licenses and Certifications - Certified Clinical Research Professional (CCRP) preferred

Education and Experience

  • Master’s Degree required; preferably in a Sciences related field
  • Senior Clinical Research Associate, Minimum of 9-10 years experience required  OR Clinical Research Associate III, Minimum of 6-8 years experience required

Work Environment - This position will take place primarily in an office, clinic, laboratory, or hospital setting.

Physical Capabilities - Ability to stand or sit at a computer for prolonged periods

Supervisory Responsibilities - Assigned Lead: May recommend the following: employee hiring, disciplinary action, and starting salaries; provide input on employee performance evaluations.

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.

 


System One

Address

Bethesda, MD
USA

Industry

Healthcare

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