Clinical Operations Associate
The Clinical Operations Associate will directly support the Development Operations Group, as well as provide general department support within those functional areas. A successful candidate will be extremely well organized, an excellent communicator, capable of effectively coordinating multiple tasks, and working closely with other members of the Development Operations group to help coordinate and execute designated activities. The candidate should be able to show flexibility with changing project/department priorities. This role will be accountable for supporting and executing assigned work under the direction and guidance of the Director, Clinical Operations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide CRO oversight of the trial master file (eTMF). Coordinate with internal departments to ensure filing of all project plans and documents outside of Clinical Operations. In conjunction with the CRO, coordinate and provide periodic review of the trial master file (eTMF), document findings and resolve discrepancies and deficiencies
- Assist with monitoring visit report review or data line listing reviews
- Develop various study documents or forms for a study and/or study specific documentation and tracking tools/metrics including inspection readiness overview of study processes and conduct (storyboard)
- Track key internal metrics for Development Operations as assigned per study or functional group
- Track, review and prepare study or departmental specific information or updates from databases, spreadsheets or other resources for a group or the department
- Provide logistical support to one or more groups within Development Operations
- Interact with all groups within Development Operations to complete assigned tasks
- Participate in departmental and study meetings as needed
- Participate in departmental process improvement initiatives
- May provide backup support to the other members of the Development Operations team as needed
- Comply with corporate policies and procedures
- Other tasks or responsibilities as assigned
KNOWLEDGE AND SKILL REQUIREMENTS:
- Bachelor’s Degree or equivalent, preferably in a life science or health science discipline
- Minimum 2 years of clinical operations or data management experience
- Strong attention to detail and excellent organizational skills
- Ability to efficiently perform multiple tasks and manage changing priorities
- Ability to identify and logistically solve problems
- Must be proficient in Microsoft Outlook, Word, PowerPoint and Excel and willing to learn new software and manage multiple platforms
- Possesses proactive approach to departmental needs
- Ability to work independently and be flexible
- Demonstrated ability to work in a team setting and exhibit a professional and enthusiastic attitude
- Excellent communication, verbal and written skills
- Ability to read and understand standard operating procedures
- Takes direction well
- PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
- WORK ENVIRONMENT: The noise level in the work environment is usually moderate.
Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.