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
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.
Responsibilities
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.
Responsibilities Include
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.
Comments/Special Instructions
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
Seniority level
Associate
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
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