Clinical Research Associate Job at Integrated Resources, San Jose, CA

  • Integrated Resources
  • San Jose, CA

Job Description

Clinical Research Associate

Candidate with Academic CRO experience would also be fine, leading the study(3-4 studies) Understands data management and documentation process Candidate who has worked on clinical trials as clinical data manager, CRF design and clinical data management plan, study maintenance Works with Clinical Programmers, CRA, Statistical Programmers, Biostatisticians and other Clinical, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. Demonstrates a general understanding of each assigned protocol, critical tasks and milestones. Ensure completeness, correctness and consistency of routine clinical data and data structure. Assists in the implementation of routine clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery. Assists in the preparation of CRF/eCRF for data collection through the regulatory approval process. Assists in implementing routine clinical research projects. Reviews study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves routine queries. Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met. The ability to problem solve and have people/project leadership skills.Knowledge of FDA regulations, support of needs for NDA and other regulatory submissions, and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems.

Job Tags

Similar Jobs

Gray Local Media, Inc

NEWS ANCHOR/MMJ - KTUU Job at Gray Local Media, Inc

 ...Assembly Atlanta and Third Rail Studios. About KTUU: Alaska's News Source has a reputation of excellence as the state's most...  ...Description: Alaskas News Source is seeking an experienced News Anchor / Multimedia Journalist (MMJ) with a proven record of enterprise... 

Kenan Advantage Group

Owner Operator Truck Driver Job at Kenan Advantage Group

 ...customer base and year-round freight Food-grade freight that is clean, consistent, and designed for long-term profitability CDL-A Driver Requirements CDL-A Minimum 12 months of recent, verifiable tractor-trailer experience Tanker endorsement & TWIC required... 

Tennessee Steel Haulers Inc.

CDL A Flatbed Owner-Operator Truck Driver Job at Tennessee Steel Haulers Inc.

As a CDL A Flatbed Owner Operator Driver, you operate your own truck hauling primarily flatbed freight for Tennessee Steel Haulers. You choose your loads without forced dispatch, run over-the-road lanes, and aim for consistent weekly earnings with reasonable home time.... 

CSC Corporation Service Company

Director, Culture and Employee Experience Job at CSC Corporation Service Company

 ...Strengthen new-hire and leader understanding of CSCs mission, values, communication norms, and expectations for success.Recognize and amplify individuals, teams, and leaders who demonstrate CSCs culture and values in action.Insights, Measurement, and AccountabilityLead... 

Bobcat Transport

Owner Ops Needed Home Daily Consistent Work TWIC Needed CDL Driver Job at Bobcat Transport

 ...are looking for experienced Class A truck drivers with a strong record of safe and reliable...  ...occasional runs.Responsibilities Class A CDL hold. Minimum of 2 years of Class A driving...  ...Compensation Gross up to $5,500 weekly. Take home pay expected to range between $2,600 and $...