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ONCOLOGY Clinical Research Associate – Pennsylvania or Ohio
PRA Health Sciences
- Clinical Operations
PRA and our employees have won numerous awards and accolades in the CRO industry. In fact, we've been awarded 2016 Top Workplaces honor by Philly.com. The Top Workplaces recognition is based solely on the results of an employee feedback survey. In addition, many of our employees have won gold, silver, and bronze medals in various categories honoring clinical research and project management.
The Regional Clinical Research Associate (CRA) completes project activities associated with monitoring functions of Phase I-IV clinical research studies. Perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs).
Performs study start-up activities related to monitoring activities.
Develops and implements innovative approaches for and participates in site recruitment, selection, and initiation activities.
Participates in CRA protocol specific training and development activities.
Develops and implements innovative approaches for the preparation and coordination of investigator meetings and participates in meeting.
Conducts site initiation visits with study site staff (train site personnel in GCP and study conduct)
Develops patient enrollment strategies with the project team and clinical trial sites.
Ensures the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
Ensures proper storage, dispensation and accountability of clinical trial materials.
Conducts interim monitoring visits (conducts source document verification of CRF against medical records).
Performs site management activities.
Conducts in-house monitoring activities as appropriate.
Review investigator regulatory files to ensure they are accurately maintained.
Maintains patient tracking records for assigned sites.
Conducts study site close-out visits.
Completes administrative activities as a member of the project team.
Bachelor’s degree or Nursing Diploma
4+ years of ONCOLOGY clinical monitoring experience required Knowledge of ICH and local regulatory authority regulations regarding drug (REQUIRED)
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities