Remote

Location: Remote

Department:  Medical Affairs

Reports To:  Clinical Research Manager

FLSA Status:  Exempt

Job Summary: 

The Clinical Research Associate monitors activities at clinical research study sites and assures adherence to study protocols and SOPs.

Essential Duties and Responsibilities:

  • Coordination and management of clinical trial sites
  • Monitor via on site visits and via remote review of data collected: if the protocol is adhered to, if the study is performed in compliance with GCP, checks if IRB approvals are still valid and in place.
  • Review in time the eCRF data collection system on completeness and timely query resolution and closure.
  • Site management: build and maintain good relations with investigators and site staff.
  • Ensure that patient enrolment on site follows agreed recruitment plan
  • Close down study centers on completion of the trial.
  • Ensure that study staff conducting the protocol has received the proper materials and instructions to enter patients into the study.
  • Ensure that the rights, well-being, and safety of human subjects are protected by verifying that informed consent procedures and protocol requirements are adhered to according to regulatory requirements.
  • Ensure data is submitted on Case Report Forms (CRFs) or other data collection tools.
  • Monitor data for missing or implausible data.
  • Maintain proper documentation of all site correspondence.
  • Assist in the training and mentoring of personnel.
  • Contact and troubleshoots non enrolling sites.
  • Perform monitoring and performs clinical closeouts in one or more programs.
  • Performs other related duties as required or assigned

Contacts:

This position may interface with all departments within the company as well as outside vendors and regulatory agencies.

Education and Experience Requirements: 

  • Bachelor’s degree in Life Sciences (e.g., Biology, Nursing, Pharmacology)
  • 1 + years site monitoring experience
  • 2 + years experience working in Oncology (as a monitor, coordinator, or nurse)
  • In-depth experience with each stage of a clinical trial (i.e. study start-up through archive) and study site management
  • In-depth experience with each type of site monitoring visit (pre-study, initiation, interim, close-out)

Certificates and License Requirements:

  • Completion of ICH/GCP course

Skills and Qualifications Requirements: 

  • Thorough knowledge of FDA GCP-ICH Guidelines and local regulatory requirements
  • Customer service orientation
  • Sound knowledge of medical terminology and clinical monitoring process
  • In depth therapeutic and protocol knowledge as provided in company training
  • Excellent verbal and written communications skills
  • Excellent interpersonal and organizational skills and attention to detail
  • Computer literacy, proficiency in MS Office

Desired Skills:

  • Strong Leadership Skills
  • CCRA Certification – Association of Clinical Research Professionals

Supervisory Responsibilities:  

  • This position requires no supervisory responsibilities.

Environment/Safety/Work Environment: 

  • General office environment.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Maintains a clean, neat, and orderly work area.
  • Adheres to Department Specific Safety Guidelines.
  • Experience working remotely/home office

Travel: 

  • Up to 50%

Physical Demands: 

  • Standing, sitting, walking, bending, reaching, manual manipulation, and lifting up to 15 pounds.