Clinical Trials Associate
Hays

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Bio - Pharmaceutical Company is seeking a Clinical Trials Associate in Foster City, CA.

Role Description

• 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 trialspecific 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.

Skills & Requirements

• BS/BA/RN in nursing, science or health field with 1+ years of related experience Preferred.
• 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.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

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Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1148223

This job has expired.