Clinical Research Associate III (CRA III)
Clinical Research Associate III (CRA III)
Pacer Staffing LLC
United States
See who Pacer Staffing LLC has hired for this role
Job Tittle: Clinical Research Associate III (CRA III)
Location: Remote
Duration: 10 Months (Possible Extension)
Work Schedule: Monday - Friday 7:00am -3:30pm or 8:00am to 4:30 pm
Qualifications
Location: Remote
Duration: 10 Months (Possible Extension)
Work Schedule: Monday - Friday 7:00am -3:30pm or 8:00am to 4:30 pm
Qualifications
- BS/BA
- Minimum of 2 years of site management and field monitoring experience
- Knowledge of applicable standards and regulations for clinical trials
- Proven oral and written communication skills.
- Proven planning skills: ability to create and track detailed project plans.
- Proven interpersonal, leadership, organizational and effective time management skills.
- Demonstrated experience in computer skills including Microsoft Word, Excel, and basic templates.
- Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion.
- Under supervision of Senior Manager, Clinical Operations, performs monitoring and site management activities to assess the progress of clinical studies at assigned investigative sites (either on site or remotely).
- The CRA will ensure all site activities are conducted in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and applicable regulations.
- Performs Site initiation, interim & close out monitoring visits.
- Verifies required clinical data entered in the electronic case report form (eCRF) is accurate and complete.
- Manages site communication and escalates to leadership in a timely fashion when needed.
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
- Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Documents activities via confirmation letters, follow-up letters, trip reports
- Site support throughout the study lifecycle from site identification through close-out
- Attends and participates in internal meetings.
- 10-month project with the potential to be extended to cover new projects if identified.
- Preferred: WFH in an EST location; Must be flexible in working with UK teams.
- Experience in women’s fertility
- IVD Study Experience
- Medidata RAVE system
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Seniority level
Associate -
Employment type
Full-time -
Job function
Research, Analyst, and Information Technology -
Industries
Staffing and Recruiting
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