Under the assignment and supervision of the Manager, Data Monitoring and Safety, the incumbent in this position is responsible for providing support to safety team in all aspects of safety related clinical trial functions including the quality of the safety work product. Coordinates the maintenance of documentation, project tracking, information / source document retrieval and meeting planning. The Safety Research Associate may be assigned general duties and functions as needed to enhance the smooth operation of any project activity.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Provides administrative and maintenance support for projects / trials within the Safety group.
· Manages calendars; makes meeting preparations with multiple parties; works with outside companies (sponsors of the trials, vendors etc.) and various in-house administrative personnel to arrange meetings; makes all travel arrangements; orders food; reserves conference rooms.
· Works collaboratively with all staff to meet project milestones and timelines.
· May inform other staff on safety processes.
· Participates, with the clinical trial team, in establishing timeline and target dates for completion of study milestones and uses analytical and monitoring resources/reports to deliver milestones on time and budget.
· Participates in project team meetings.
· Prepares documentation and media (i.e.. Angios; QCA) for Clinical Event Committee (CEC) meetings as requested.
· Supports post meeting activities to include meeting minutes for CEC & DSMB meetings as requested.
· Reviews documents for formatting, spelling, details and quality prior to submission to external audiences.
· Develops adjudication forms upon request.
· Remains up-to-date in all department and foundation standard operating procedures.
· Participates in developing and maintaining Device / Drug Safety Information (DSI) infrastructure such as the drafting and/or reviewing of SOPs, guidelines and work instructions.
· Participates in the development and review of corrective action plans as requested on internal / external audits and implements plans as required.
· Maintains study-related documents (protocol, investigator site file binders, manual of operations, regulatory binder, initial and updated study documents, etc.) to appropriate parties and works collaboratively with QA.
· Responsible for tracking all essential study related documentation using internal Data Management system
· Communicates with Project Manager for problem resolution.
· Process billing receipts and order supplies.
· Arrange meetings; coordinate with doctors and staff for scheduling.
· Performs additional duties as assigned.
· Bachelor’s degree preferably focused in healthcare or life sciences with 1-2 year of experience in safety / clinical trials as a trial assistant or similar role in a commercial, scientific, laboratory, or administrative environment.
· Must be proficient in Microsoft Excel, Word, and Outlook; basic understanding of Visio, File Maker Pro and Access is helpful.
· Must be detail-oriented.
· Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike.
· Ability to multi-task and interface with users who are working under deadlines; ability to set priorities and excellent organizational planning, project management and time management skills.
· Ability to analyze information and solve problems relating to information gleaned from study documentation.
Choice of health plans include medical, dental and vision coverage. Company-paid short-term and long-term disability and life insurance. Health and dependent care flexible spending accounts. Pre-tax travel expenses through TransitChek program. 401(k) plan. Generous paid time off (PTO). Ten paid holidays each year.
To be considered for this opportunity, please submit your resume, and refer to job title "Safety Research Associate” in your cover letter.
Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day www.crf.org
CRF is an equal opportunity employer.
Job Type: Full-time
Pay: $50,000.00 - $55,000.00 per year
- 401(k) Matching
- Dental Insurance
- Disability Insurance
- Employee Discount
- Flexible Spending Account
- Health Insurance
- Life Insurance
- Paid Time Off
- Parental Leave
- Referral Program
- Tuition Reimbursement
- Vision Insurance
- Clinical Trials: 1 year (Preferred)
- Waiting period may apply
- Only full-time employees eligible
- Temporarily due to COVID-19