Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Pleasanton

Description

ESSENTIAL RESPONSIBILITIES:
Participates in the design, planning, implementation and overall direction of clinical research projects; May co-ordinate the activities of relevant colleagues within the Company and external parties to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well. 
Travels to field sites to monitor studies. 
Receives general instructions; plans and prepares studies. 
Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents 
Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites. 
Collects and maintains legal and regulatory documentation, as applicable. 
Assumes responsibility for training and coordinating certification of study site personnel. 
Ensures accurate and complete study management/data collection and transfer to data management  
Ensures site compliance with regulations and study protocol. 
Monitors the sites and provides technical assistance, as necessary. 
Assists, prepares and manages study timelines 
Manages material logistics for the studies. 
Conducts reference material testing in-house. 
Organizes investigator meetings, as necessary. 
Participates in Project Team Meetings. 
Keeps informed of trends and developments in clinical research. 
Knows and effectively uses the broad concepts of a particular field or specialization to resolve problems of limited scope and complexity. 
Analyzes alternative approaches to solve problems or develop new perspectives on existing solutions.
MINIMUM QUALIFICATIONS:
Formal Training/Education:
Bachelor degree in scientific discipline or related field required, or equivalent combination of education and work experience.
Experience:
Sr. CRA - 5+ years of experience in clinical study coordination, clinical site monitoring or clinical study management is required, 7+ preferred.
Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) is preferred.
A background in biomedical/healthcare services with laboratory experience preferred.

Knowledge, Skills, and Abilities:
Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint). 
Excellent writing and verbal communication skills. 
Well organized and detail oriented. 
Impeccable record keeping and filing skills. 
Excellent time management skills. 
Ability to give presentations and teach others. 
Ability to work effectively in a team, and also work independently on assigned tasks 
TRAVEL REQUIREMENTS:
Travel Requirement: Approximately 30% of time travel domestic and/or international.

About the company

Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.

The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.

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