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13 days old

Clinical Research Associate

Technical Resources International, Inc
Bethesda, Maryland

Responsibilities

  • Performs site monitoring and site management activities for sponsored clinical studies; primarily Phase I and II, with limited Phase III and IV, in accordance with regulatory requirements and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP)
  • Performs on-site pre-study/qualification, initiation, routine, and close-out visits; trains site study staff; prepares site visit reports and provide assistance to site staff in resolving deficiencies
  • Reviews data remotely, interfaces with data management team as appropriate
  • Provides input on or writes sections of Clinical Monitoring Plans and Manuals of Procedures; including familiarity with Risk-based Monitoring is a plus.
  • While not on travel, performs in-house CRA duties, such as:
  • Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.
  • Assist in protocol, Manual of Procedures, Informed Consent, and CRF review.
  • Ad hoc requests by management in support of departmental initiatives.
  • Develops and demonstrates understanding of and applies therapeutic area knowledge to assignments and project-related issues.
  • Appropriately resolves issues related to trial monitoring and management with guidance from Project Manager.
  • Decisions are made independently and with some supervision from Project Manager or other Director/Manager.
  • Tasks are primarily intellectual and require exercise of discretion and independent judgment, while understanding when issue escalation is required.

Requirements

  • Working knowledge and experience in application of FDA and ICH/GCP guidelines.to monitoring activities
  • Good communication, organizational, and writing skills.
  • Proficient in use of Microsoft Office suite applications, with ability to develop and apply efficient computer tools to carry out job functions.
  • High attention to detail, ability to work in a team environment.
  • Dependable, assumes responsibility for on-time delivery of work product in accordance with TRI or client SOPs and templates.
  • Ability and availability to communicate with sites in different US time zones.
  • Has the ability to travel (on avg. 50% of time) on site visits of 2-4 days duration, international travel possible.
  • BS/MS/RN or equivalent in scientific or health care field; CRC experience a plus.
  • Four years of pharmaceutical, clinical, or biological research experience with 2–3 years of CRA field monitoring experience (i.e., conducting on-site visits).
  • Oncology and vaccine trial site monitoring experience a plus.

Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.

Job Type: Full-time

Experience:

  • Relevant: 3 years (Preferred)

Work Location:

  • One location

Benefits offered:

  • Paid time off
  • Health insurance
  • Dental insurance
  • Healthcare spending or reimbursement accounts such as HSAs or FSAs
  • Retirement benefits or accounts
  • Education assistance or tuition reimbursement
  • Gym memberships or discounts
  • Workplace perks such as food/coffee and flexible work schedules

Categories

Posted: 2019-07-02 Expires: 2019-08-01

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Clinical Research Associate

Technical Resources International, Inc
Bethesda, Maryland

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