Clinical Research Associate
POSITION SUMMARY: Responsible for conducting activities assigned to a Clinical Research Associates (CRA) who helps to assist clinical team for site qualification, selection, monitoring, start-up and close-out visits. Ensures that duties are performed within line Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization - Good Clinical Practice (ICH-GCP).
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Evaluate clinical trial resourcing requirements for qualification, training, monitoring and support of sites during the conduct of the trials. The resourcing plan must balance the cost of travel within geographies with expertise within available resources.
- Develop a monitoring plan for each clinical trial.
- Liaise with doctors/consultants or investigators conducting the trial as required to insure the study and monitoring activities are meeting expectations.
- Oversee the setup of the trial sites; ensuring each site has the appropriate trial materials to conduct the study.
- Oversee site activation process for each study.
- Develop and monitor metrics to evaluate the monitor and site performance. In the event of performance concerns, evaluate cause and mitigate risk to study.
- Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring.
- Track patient enrollment and recommend solutions to monitoring staff to increase appropriate enrollment of qualified subjects.
- Provide support for the processing of data queries.
- Write monitoring visit reports.
- Develop and execute a plan to close trial sites on completion of the trial and perform associated closeout activities.
- Ensure adherence to GCP, Standard Operating Procedures (SOPs) and study protocols.
- Ensure adherence for regulatory compliance of investigational sites with SOPs, FDA regulations, and ICH guidelines.
- Coordinate with team data management activities.
- Generate protocol Informed Consent template.
- Review site Informed Consent forms and site related materials as needed.
- May prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, Pharmacovigilance Plan, and Informed Consents.
- Assist with protocol development and study report completion.
- Assist with CRF development.
- Assist with investigator meetings.
QUALIFICATIONS / EDUCATION:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Bachelor's degree (BA/BS) or nursing degree (associate of applied science or above). Clinical research or life science degree preferred.
- Certified as a CRA, e.g. CCRA , CCRP, or other CRA certification strongly preferred.
- Three or more years of relevant experience with at least two years of experience in medical device.
- Prior study management experience.
- Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
- Demonstrated ability to work independently and in a team environment.
- Proficiency with MS Office.
- Excellent oral and written communication skills and strong organizational abilities.
- Ability and willingness to travel 25% - 50% of the time (internationally and domestically).
Pulse Biosciences, Inc. is an immuno-oncology company developing a proprietary oncolytic electroceutical therapy based on its Nano Pulse Stimulation (NPS) platform. Preclinical studies using NPS on solid tumors in murine models has demonstrated that NPS enables effective local tumor control and initiates an adaptive immune response with a vaccine-like effect by inducing immunogenic cell death.
Pulse Biosciences, Inc. (PLSE, Nasdaq) corporate headquarters is located in Hayward, CA.