Clinical Trials Management AssociateUnited States - California - Santa Monica, United States - Washington - Seattle, United States – RemoteClinical Development & Clinical OperationsRegular
The Clinical Trials Management Associate is a primarily an in-house sponsor position (although some travel is required) who will oversee multiple aspects of clinical trial conduct including study start-up, document generation and review, tracking of samples and enrollment of study participants.,. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The position will report to the Senior Clinical Trials Manager of Clinical Operations.
NOTE: This position can be located onsite in Santa Monica, CA, or Seattle, WA. Remote will be considered for the right candidate.
Responsibilities include but, are not limited to:
- May assist in the review of study-related or essential study start-up documents as they relate to the supported clinical trials as delegated by the study manger (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
- With guidance, plays a direct role in clinical studies execution, such as managing components of studies and acting as a member of the study team
- Manage vendors
- Works with multiple contract research organizations to communicate detailed timelines and ensure that transferred obligations and performance expectations are met. Provides corrective instruction, as necessary, when performance expectations are not being met.
- Attends internal team and other meetings as required.
- Provides training, as necessary, at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences.
- Creates and reviews site feasibility assessments required for study participation.
- Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations.
- Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate to Senior Manager.
- Prepares metrics and updates to key deliverables for management.
- Assists in the resolution of clinical trial queries for interim analysis, primary analysis and final database locks.
- Prepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team
- Assists in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol.
- May participate in special projects
- Familiar with standard medical / scientific terminology
- Other duties as assigned.
- BS/BA/RN in nursing, science or health field with 2+ years of related experience
- Oncology/Hematology experience considered a plus
- Willing/Able to travel at least 25% (possibly more)
- Ability to manage time demands, incomplete information or unexpected events
- Display strong analytical and problem solving skills
- Attention to detail
- Outstanding organizational skills with the ability to multi-task and prioritize
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Working knowledge of transplant patient care and apheresis collection a plus