Clinical Trial Assistant
1910 E. Innovation Park Drive, Bldg 5E Tuscon, AZ 85755
Bayside Solutions is seeking a Clinical Trial Assistant to be part of our client’ s team in the East Bay Area. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com
Clinical Trial Assistant
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Receipt, processing, tracking, storing, packaging and shipping of Pathology slides.
- Materials (supplies, binders, labels, etc.): Work with study teams to identify specifications and develop study related materials to those specifications. Prints labels for all types of materials.
- Receiving: Receives, inspects and inventories Clinical Trial Materials (binders, labels, kits, reagents, consumables) insuring appropriate quality, quantities and storage conditions (warehouse, coolers, freezers, etc.), completing relevant documentation as necessary, establishing electronic inventory records, and communicating with Clinical Teams.
- Material Management: Maintains electronic and physical inventories of Clinical Trial Materials, relabels marketed products for investigational and/or research use as necessary, tracks expiration dates.
- Picking / Packing / Shipping: Follows moderate to complex instructions from Clinical Team to fill shipping requests of Clinical Trial Supplies and/or Samples insuring accuracy of items and quantities, appropriate packing materials and shipping conditions (e.g., frozen, refrigerated and ambient), as well as shipping instructions to insure compliance with all DOT, IATA, and local and federal regulations.
- Creates, maintains and audits Trial Master Files (TMF - paper and electronic), including interacting with internal and external study team members and investigator staff for collecting and managing related study documents.
- Establish good working relationships across all Life Cycles and Facilities groups to effectively deliver work objectives.
- Accurately and effectively communicate services / capabilities, needs, issues, material inventories, and project status with all necessary groups and individuals (Manager / Supervisor, Study Teams, Facilities, etc.).
Summary of Qualifications:
- High School Diploma required. Associates or Bachelor’ s Degree preferred or equivalent combination of education and work experience.
- Clinical Trial Support experience in Diagnostic, Medical Device, and/or Pharmaceutical industry preferred
- 2– 4 years of related experience minimum, 4+ years of industry experience preferred.
- Warehouse / hands-on material management experience and/or Trial Mater File / electronic Trial Master File management experience required
- Able to communicate clearly and accurately both written and spoken in English
- Strong customer service orientation
- Self-motivated and displays initiative
- Advanced knowledge of clinical trial processes and regulatory requirements in Diagnostic, Medical Device, and/or Pharmaceutical industry, including GCP and ICH guidelines
- Able to understand and follow detailed and complex work instructions
- Attention to detail and accuracy in work.
- Effective time management and organizational skills.
- Experience with inventory management and using copying/printing equipment
- Strong computer skills including proficiency in using Microsoft Word, Excel and PowerPoint.
- Knowledge of applicable protocol requirements (as provided in company training).
- Problem solving skills and demonstrated project delivery