Principal Clinical Research Associate
The Principal Clinical Research Associate (CRA) is an integral member of the Clinical team. This position manages and oversees study site activities to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines and Pulse Biosciences’ operating procedures (i.e. SOPs). This position requires detail-orientation, organization, and a strong desire to learn clinical research processes continuously. Please note: This is not a remote position.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provides case support to research sites across multiple studies.
- Demonstrates strong written and verbal communication skills.
- Responsible for writing clinical reports, protocols, informed consent, case report forms, study newsletters, and other study-related documents in consultation with the cross-functional project team, data management and biostatisticians.
- Review data listings and tables for clinical reports.
- Assist with the conduct of Physician Committees. (e.g. CEC, DSMB, etc.)
- Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan and applicable SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations.
- Delivers high quality written trip reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.
- May support submission of studies to IRB/IEC and regulatory authorities.
- Verifies the rights and well-being of study subjects are protected.
- Verifies that written informed consent was obtained before each subject’s participation in the study.
- Verifies that the investigator is enrolling only eligible subjects.
- Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.
- Performs Investigational Product (IP) accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
- Verifies and supports the recording and reporting of adverse events/serious adverse events. Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.
- Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.
- Participates in site audits, as requested.
- May assist the Clinical Trial Manager with coordination and management of the project budget and project invoicing.
- Attends and participates in team teleconferences/meetings providing mentoring and training.
- Provides mentorship, training and direction to Clinical Research Associates.
- Other duties as assigned by Clinical Trial Manager/Research Manager and per project-specific requirements.
Supervisory Responsibilities: None
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.
- Minimum BS/BA degree.
- Minimum 6+ years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
- Certified as a CRA, e.g. CCRA , CCRP, or other CRA certification strongly preferred.
- Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting.
- Skills to mentor and train other CRAs in a positive and effective manner.
- High energy and results-oriented individual who is mature and successful in a business environment.
- Finance and budgeting knowledge.
- Proficient in Acrobat Adobe, Microsoft Word, Excel, Power Point, and Smartsheet; and the ability to quickly become proficient in a variety of other computer software programs.
- Proven organizational abilities, and excellent oral and written communication and presentation skills.
- Strong customer focus.
- Ability to perform well-defined procedures and work independently with minimal assistance.
- Ability to make independent decisions and take responsibility within a fast-moving environment.
- Ability to travel on an average of 50-75%, depending on project needs. International travel may be required.