CELL THER CLINICAL OPS SPECIALIST
Job posting number: #7072689 (Ref:hlj_28218)
Posted: December 1, 2020
Application Deadline: Open Until Filled
H. Lee Moffitt Cancer and Research Institute is a modern facility in Tampa, Florida. We strive to be the leader in understanding in the complexity of cancer through team science and applying those insights for human benefits. Be part of the cure by joining Moffitt's team of over 800 research faculty scientists, career staff scientists, postdocs, graduate students and support staff dedicated to cancer research.
§ Opportunity to join a NCI designated comprehensive cancer center in production of novel cellular therapy treatments for cancer patients.
§ Participation in cutting edge adoptive cellular therapy treatments.
§ Involvement in the rapidly growing multiple clinical trials within the cell therapy area.
The Ideal Candidate
Experience in utilizing project management/administration techniques Working knowledge of Adoptive Cell Therapy.
Understanding of good documentation practices and requirements.
The successful candidate will be a strong communicator, engaged, and will work closely with members of the Cell Therapy Team.
Exhibit interest and excitement in participating in the production of cellular products
§ Utilizing project management/administration techniques to coordinates and supports Cell Therapy Core (CTC) clinical trials operations.
§ Works closely with CTC management and with internal and external organizations to initiate and maintain processes which meet all Quality Management and Regulatory guidance for CTC involved clinical trials
§ Attends CTC sections of Pre SIVs and SIVs with CTC management or designee
§ Assist in providing required documentation for IBC, preSite checklist, and trial documentation.
§ Coordinates receipt of supplies for externally sponsored or multisite product shipping and receiving.
§ Schedules courier pickup and delivery as required for clinical trials.
§ Ensures the proper conditioning of shipping containers as required
§ Understands and completed documentation using good documentation practices
§ Monitors inventory of supplies for shipping, receiving, and administration provided by sponsor. Includes ordering as required and maintaining inventory logs as applicable
§ Performs regular data checks and internal quality audits, recommend changes when appropriate.
§ Assist CTC management or designee in preparation for sponsor audit and monitoring visits
§ Act as liaison with clinical trial monitors and sponsors to track scheduled collections, receipt, and
§ Comply with the facility's standard operating procedures and policies which incorporate the cGMP/cGTP, FACT, CAP and AABB regulatory standards applicable to cellular therapy product production and analysis.
§ Handle fresh and frozen cellular products for shipment and infusion.
Credentials and Qualifications:
§ Associate's degree or equivalent in related Life Science field; Bachelor's preferred.
§ Minimum of one year experience in laboratory operations, clinical trial coordination, project management or equivalent experience.
§ Demonstrated knowledge of one or more of the following topics: collection, processing, storage, and/or shipping of biological specimens; documented working knowledge of data entry, databases and inventories; performing data checks; and/or document version control.
§ Self-starter and self-motivated.
§ Excellent analytical, written and verbal skills.
§ Proficient in Microsoft Office Suite, including Word, Excel, and Outlook. Demonstrated ability to work independently to achieve expected outcomes
Mission To create a Moffitt culture of diversity and inclusion as we strive to contribute to the prevention and cure of cancer. Vision Moffitt Cancer Center is recognized as the model wherein the diversity of our employees and communities is valued and supported as essential components to contributing to the prevention and cure of cancer. The cancer center is an equal opportunity employer. It is the policy of the cancer center to prohibit unlawful discrimination and harassment of any type and to afford equal employment opportunities to workforce members and applicants, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, disability, genetic information, veteran’s status or any other characteristic protected by federal, state or local law.