|
WHAT
IN
Clinical Research Associate 2
Job
Biomarin
US
-
Novato,
California
Job Code - 09-0097
Position - See Job Description
Job First Active on: Monday, October 26, 2009
APPLY TO THIS JOB (You will be applying directly to Biomarin for this position!)
JOB DESCRIPTION: Clinical Research Associate 2
SUMMARY DESCRIPTION
Responsible for the conduct and management of clinical studies, focusing in the areas of protocol development, study planning and implementation, site monitoring and management, enrollment and data quality.
RESPONSIBILITIES
• May represent department at team meetings, may lead teams and participates in collaborative efforts (e.g. protocol development, CRO selection etc...).
• Responsible for feasibility assessments for new studies.
• Manages TMF contents and responsible for TMF reconciliation.
• Responsible for the preparation of study documents (i.e., consent forms, site instructions, etc.).
• Responsible for the preparation of study training and investigator meeting materials and presents at study training workshops and investigator meetings.
• Responsible for the development and preparation of study start-up, maintenance, and close-out activities, including monitoring plan.
• Responsible for the adherence to timelines, study quality and budget for assigned studies.
• Responsible for the preparation of training material and training of internal and external staff.
• Responsible for vendor identification and evaluation.
• Participates in the oversight of vendor performance and may be responsible for communicating expectations and tracking performance metrics.
• May lead the protocol development process and ensures that clinical protocols and amendments are reviewed for consistency and quality of content.
• Responsible for the monitoring of clinical sites, may include complex studies.
• Responsible for the identification and qualification of clinical investigators.
• Responsible for the development of investigator site budgets.
• Responsible for soliciting Vendor costs and capabilities for the evaluation and selection process.
• Has clinical knowledge of therapeutic area or disease prior to executing monitoring duties and is able to explain basic aspects of the therapeutic area to study team.
• Concrete understanding of study phases.
• Other duties as assigned.
EDUCATION
Bachelor’s degree in biological science preferred.
Combination of education and work experience providing competencies to perform the required accountabilities specific to position.
EXPERIENCE
• 3-4 years industry experience, including a minimum of 3 years clinical research experience.
• Competent in the skills for the Clinical Research Associate I and the following:
o Delegates work appropriately
o Independently develops study documents and processes
o Demonstrated ability to monitor all visit types independently
o Understands the needs of stakeholders and able to develop action plans
o Discerns urgency of issues and takes appropriate action
• Ability to travel is required.
EQUIPMENT
Computer work, utilizing common business software programs.
CONTACTS
Internal: Clinical Project Team, GCP Compliance, other Clinical Operations staff
External: CRO personnel, other vendor personnel, counterparts or appropriate team members at partner companies.
REQUIREMENTS - QUALIFICATIONS: Clinical Research Associate 2
See information above.
Biomarin
Back To Results
Apply to this job!
View Company Jobs
Free Career Test
Your Resume on 75 Job Sites
|
The goal of CareerTopJobs is to help candidates find
jobs more easily, like the job listed on this page, "Clinical Research Associate 2, in Novato, California - Biomarin". We hope CareerTopJobs will become your job source for finding open job positions in the
Biotechnology and
Pharmaceutical industry job market.
