Clinical Research Associate
The Senior Clinical Research Associate (Sr. 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Assists in the preparation of clinical study protocols, CRFs, regulatory binders, brochures, and study manuals, and all relevant study documentation.
- Maintain compliant trial master files of all Pulse Biosciences’ clinical studies and ensure each site is maintaining its regulatory binder as required.
- Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.
- Conduct onsite initiation,
- Conducts Qualification, Site Initiation, Regulator Interim, and Close-Out monitoring visits to orient and train site personnel regarding the protocol and applicable regulatory requirements.
- Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits.
- Performs training of investigators and study coordinators on use of devices and study, as needed.
- Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators.
- Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites following the monitoring plan and applicable SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations. This includes the management of multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
- Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH and/or FDA GCP Guidelines.
- Ensures quality of data submitted from study sites and assures timely submission of data.
- Supervises overall activities of site personnel over whom there is no direct authority and motivates /influences them to meet study objectives.
- Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.
- Ensures documented follow-up to all outstanding issues, within the scope of this position profile.
- Appropriately escalates serious or outstanding issues to line manager and project team members.
- Facilitates the Regulatory Compliance audit process, as needed.
- Provides monitoring assistance to site monitor colleagues, as requested, in addition to serving as a mentor to other colleagues as assigned.
- Proactively communicates and escalates with all internal and external stakeholders any issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.
- Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.
- Interacts and builds professional and collaborative relationships with all study personnel (study coordinator, investigator, pharmacist), peers, and Sound office-based personnel.
- Uses multiple technologies to foster, maintain, and enhance open communication
- Recognize potential obstacles and work to resolve them within set timelines.
- Monitor emerging industry and regulatory trends to help integrate new requirements into department procedures (i.e. action items, protocol deviations, adverse events, etc.).
- Complete projects and tasks consistent with corporate objectives.
- Attend relevant symposia, meetings, and conferences as needed.
- Support safety monitoring and processes as needed.
- Participate in department systems and development initiatives including related trainings (i.e. Electronic Data Capture, Clinical Trial Management System, etc.).
- Perform other duties as assigned by Clinical Affairs management.
QUALIFICATIONS AND 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 of a BA/BS degree in a health-related field with 4 or more years clinical research experience or as a CRA or equivalent.
- Interim monitoring experience essential, for a medical device company preferred.
- Strong knowledge of US and international clinical regulations and guidance.
- Exhibits a high level of flexibility and sets an example for the department when facing changes such as program priorities, protocol modifications, enrollment challenges, etc.
- Employs good fiscal management to conserve the costs of departmental operation and controls travel expenses.
- Proficient in Acrobat Adobe, Microsoft Word, Excel, and MS Project; and the ability to quickly become proficient in a variety of other software
- Excellent oral and written communication skills and critical thinking skills
- Understanding of medical terminology
- Ability to perform well-defined procedures and work independently.
- Ability to exhibit good judgment, be creative, and achieve aggressive goals
- Ability to make independent decisions and take responsibility within a fast-moving environment.
- Ability to travel up to 50%. Overnight travel is required; International travel may be required.
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.