The incumbent is responsible for supporting and managing the execution of the day to day functions in the Clinical Research and Development area. These functions include helping to develop study protocols, organizing study meetings, monitoring the studies, keeping track of study progress, collecting the data, and helping to summarize the study data and produce appropriate publications. Finally, the incumbent will be responsible for explaining the preparation and use of Prolacta products to study sites and be available to respond to investigators and their staff.
Primary Duties and Responsibilities
· Provide management support for Prolacta's clinical research program.
· Provide technical support for inquiries on Prolacta's products, particularly regarding those associated with clinical research centers.
· Oversee the data collection and management of the data from Prolacta’s clinical research program
· Support IND and other regulatory filings for Prolacta’s studies that require such regulatory support
· Experience in cGMP for Investigational New Drugs (IND) trials
· Serve as primary point of contact for assigned IND Investigational New Drug clinical studies.
· Participate and provide clinical representation in new product development and clinical research project team meetings.
· Have current ICH training and GCP certifications.
· Participate in the identification, evaluation, and selection of clinical study sites and investigators.
· Develop, or assist with development of study design, protocols, case report forms and other study-specific documents essential for the appropriate implementation of clinical investigations.
· Work with Project Manager, and investigators to ensure optimal compliance and performance to the protocol, regulatory requirements, discrepancy reporting and ethical practice.
· Assist with preparation and execution of Investigator meetings
· Ensure ICH International Conference on Harmonization, and GCP Good Clinical Practice procedures are followed in all study aspects.
· Participate in vendor selection and establish plans for data processing and data review with vendors. Manage CROs, Clinical Research Organizations, consultants, and/or Clinical Research Associates.
· Monitor clinical trials through all phases.
· Be familiar with nutritional trials, and IND filing
Job Requirements and Qualifications
RN or Bachelor's degree in a biological science with a minimum of 10-15 years of clinical research experience is acceptable.
· Reasonable knowledge of the workings of clinical studies based on at least 3-5 years’ experience in working with such research in a pharmaceutical/biotechnology environment
· Good documentation skills required
· Experience in a hospital setting a plus
· Experience managing CROs required
Other Knowledge, Skills and Abilities
· Previous experience working in either an academic or commercial clinical trials environment as part of an Investigational New Drug Application necessary
· Knowledge of FDA and other regulatory agency rules and regulations required.
· Able to create and manage a budget
· Ability to work without supervision
· Effectively interview and select candidates
· Handle conflict management and bring resolution
· Effective relationship building skills
· Ability to produce and present clear, concise and professionally written communications and presentations
· Performance Management, effective coaching and directing of others
· Positive attitude and motivation
· Ability to operate in a complex matrix environment
· Visionary and forward-thinking
· High level of business acumen
· Project management
· Strong PC skills, MS Outlook, Word, etc.
· Must be able to work under pressure, meet deadlines, and be flexible when working on multiple projects simultaneously
· Strong Critical thinking and decision-making skills
· Strong business ethics
· Scorecard management
Work Environment (Location, travel, shift, on-call, etc.)
· This job operates in a professional office environment. This role routinely uses standard office equipment such as laptops, smart phones, photocopiers/scanners, shredders and filing cabinets.
· This is a full-time position, and hours of work and days are Monday through Friday, 8:30 a.m. to 5 p.m.
o About 40% time in the US, and possibly sporadic overseas travel.
o City of Industry, CA and Duarte, CADirect Reports
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
“Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer.” Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.