Clinical Supplies Operator
Fort Worth, TX
We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Supplies Operator, in Fort Worth, TX . The Clinical Supplies Operator supports secondary packaging and distribution of clinical supplies to support the Medical Device portfolio. . Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Responsible for labeling/kitting, distribution and accountability activities in support of the Medical Device portfolio
- Generates secondary packaging and distribution instructions; creates airbills and other shipping documentation
- Demonstrates an understanding of cGMP, and Annex 13 regulatory requirements such that clinical supplies documentation produced and distributed remain compliant throughout the chain of custody
- Creates, updates, reviews, maintains and archives records and other key documents to provide track and trace evidence for every aspect of the secondary packaging and distribution of investigational product in a cGMP state
- Accountability for specific record types will be based on job assignments. If label printing is a part of job assignments, demonstrates knowledge of labeling requirements along with the knowledge of printing clinical labels
- Demonstrates good working knowledge of inventory management best practices. This may be inclusive of any of the following, log books and their correct entry, WIP, quarantine, retention samples, reference samples, released goods, returned and discarded goods
- Additional responsibilities include shipment tracking, label creation, drug accountability and copying/filing of GMP documentation
- Some experience with labeling, packaging and/or shipment of clinical supplies is a plus
- Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements preferred
- Some experience in Clinical Trials, to understand clinical needs
- Excellent organizational and documentation skills
- Excellent communication & customer relation skills
- Excellent written and spoken English
- Great attention to detail
- High School Diploma
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.