Clinical Trial Specialist/Senior Specialist
LOCATION: South San Francisco
DEPARTMENT: Clinical Operations
DIVISION: Product Development
REPORTS TO: Manager, Clinical Operations
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages.
Effective Date: February 2021
The Clinical Trial Specialist provides support to the Clinical Trial Manager and other clinical staff in the day-to-day operational execution of up to 4 clinical trials. Assists in the coordination of documentation associated with the conduct of clinical trials, and occasionally assists with department projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provides support to clinical operations trial activities including, but not limited to, maintenance of documentation, information retrieval and tracking
- Collects, disseminates, maintains and/or tracks regulatory documents as required
- Collects, logs and files documents received from the clinical sites, CROs, vendors, etc.
- Assists in coordination of study logistics: clinical supplies, drug shipments, laboratory kits, biological samples
- Creates and maintains patient enrollment and patient visit trackers/logs
- Requests confidentiality agreements, study agreements, and clinical site budgets; tracks same documents to their final approval.
- Performs data entry and/or verification into designated clinical tracking systems, including collection of information from designated clinical team members, CROs, vendors, etc.
- May manage ancillary/supportive vendor(s) with the oversight of a Clinical Trial Manager
- May travel with senior level clinical staff on co-monitoring visits to observe and assist at site selection, site initiation, site monitoring, and closeout visits
- Prepares study binders, spreadsheets, site visit packets
- Ensures all documentation are in a state of audit-readiness
- Coordinates the shipment of study-related supplies to the clinical sites
- Prepares and disseminates meeting agendas and minutes
- Assists with planning, preparation, and participation in Investigators’ meetings
- Performs additional administrative support duties, as assigned
- Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry, FDA, ICH guidelines and Good Clinical Practices
- High school diploma or general education degree (GED) and four years of related experience; or,
- AA degree in related discipline and two years of related experience; or,
- BS/BA degree in related discipline and one year of related experience; or
- Typically requires a minimum of four (4) years of related experience and/or combination of experience and education/training.
- Experience in Biotech/Pharmaceutical industry preferred
- Familiarity with medical terminology and/or GCP guidelines strongly preferred.
- Applies technical standards, principles, theories, concepts and techniques.
- Strong organizational and analytical skills are required.
- Demonstrated success in problem solving.
- Experienced professional with a full understanding of area of specialization.
- Good communication skills both oral and written are a must.
- Working knowledge of MS Word, Excel, and PowerPoint is required, and applications as needed for the position.
- Develops solutions to routine problems of limited scope.
- Detail oriented.
- Ability to work in a team environment.
- Self-motivation, eagerness to grow professionally and commitment to self-development.
- Occasional travel may be required
- Works on assigned problems of moderate scope with analysis of situation or data required.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Builds productive internal and external working relationships.
- Uses professional concepts and company’s policies and procedures to solve a variety of routine problems.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.