Sr. Clinical Trial Specialist, Clinical Operations - United States
- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- The Senior Clinical Trials Specialist 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, enrollment of study participants, as well as scheduling of treatment with investigational product.
- The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.
- The position will report to the Study Manager or Senior Study Manager of Clinical Operations.
- Prepares and/or reviews 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).
- 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.
- Participates in the development, review and implementation of departmental SOPs and processes.
- Other duties as assigned.
- Bachelor’s degree in nursing, science or health related field required with at least five or more years of related experience.
- At least two years of clinical trial experience with oncology, hematology or related therapeutic area experience considered a plus
- Must be willing to travel at least 25% (possibly more)
- Ability to manage time demands, incomplete information or unexpected events
- Must display strong analytical and problem solving skills
- Attention to detail required
- 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
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of this successful, fast growing company.
- A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.