Clinical Research Associate
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).
Ability and willingness to travel 25% - 50% of the time (internationally and domestically).
Pulse Biosciences is a novel medical therapy company bringing to market its proprietary CellFX™ Nano-Pulse Stimulation™ (NPS™) platform. The Company’s CellFX NPS platform provides a novel, precise, non-thermal, treatment technology delivering nanosecond duration energy pulses that impact cells in treated tissue while sparing acellular tissue. NPS’s unique mechanism of action disrupts the functions of internal cell structures while maintaining the outer cell membrane initiating a cascade of events within the cell that results in regulated cell death. The novel characteristics of the Company’s NPS mechanism of action has the potential to significantly benefit patients across multiple medical applications, including dermatology, the Company’s first planned commercial application. In pre-clinical studies, NPS has demonstrated an ability to induce immunogenic cell death in several cancer cell lines. The Company believes its NPS platform may play a role in immuno-oncology as a focal tumor treatment that can initiate an adaptive immune response. More information can be found at www.pulsebiosciences.com.
Pulse Biosciences, Inc. (PLSE, Nasdaq) corporate headquarters is located in Hayward, CA.
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All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.