Job Title: Clinical Research Associate - B
Location: Alameda, CA (94502)
Shift 8:00am to 5:00pm
Duration: 6 Months with possible extension
Payrate starts at $55/hr on W2
Job Responsibilities:

• Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines.
• Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
• Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary.

Experience:

• 3-5 Years Experience Level

Team Overview:

• Have 2 clinical managers and 2 study leads.
• They have CRA under each managers comprising of 4-9 individuals.
• They are responsible for certain type of clinical trials.
• Their team is in the US and UK. They execute most of the UK and ex-US studies.

Position Overview:

• Generate monitoring reports tracking action items from those visits.
• Participate in study startup activities.
• Prepare site for study startup, work with data management to draft CRF.
• Make sure protocols are in compliance at site to the ICH, and regulatory guidelines.
• They usually participate with data management team, to design case verification study
• There are cross-functional meeting, provide updates and discuss those in meetings
• They use the VEEVA system.

Must Have Skills:

• Have monitoring exp, conducting site visits- SQV, SIV, IMV, COV
• Exp and ideally would have is 3-5 years of direct monitoring exp -
• 5 years of exp with bachelors
• 3 years of exp with Masters
• 2 years of exp with Ph.D.
• fall regulatory, documents related to study conduct
• Teamwork,
• Interpersonal and communication.
• Build report externally for site relationship.
• Independent
• Able to solve problems.
• Flexible with changing priorities
• GCP, clinical and regulatory activities,

MS Suite, excel, PowerPoint