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Clinical Research Associate - Home Based
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PRA International
Clinical Research Associate - Home Based - Southeast or Central Regions
Location: Raleigh, North Carolina-Raleigh/Durham-RTP 27607
Posted on: 1:52 PM, Wednesday, February 07, 2007
Position type: Full time
Job Code: 4997BR
Required education: Bachelor's Degree
Area(s) of expertise desired: Clinical Research
Description
PRA International is currently hiring full-time salaried Clinical Research Associate employees to work from home and to travel regionally. If you are looking for a company who can provide growth opportunities, a challenging career, and a good balance between work and your life outside of work then PRA International has your next career waiting for you. The following information outlines the position and the qualifications. If you feel after reviewing the requirements that this position is what you are looking for please apply. Also please forward me a copy of your resume to westchristopher@praintl.com so that I can respond sooner to your interest in this position.
Requirements
Job Specifications
Monitors the progress of clinical studies at investigative sites, and ensures that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
ACCOUNTABILITIES
Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines
o Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies
o Provides regular clinical status information to team members and project management
o Performs billable work in accordance with PRA policies, procedures, and Standard Operating Procedures
o Works closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff.
o Communicates common site trends to Lead CRA and other project team members
Performs investigative site file reconciliation; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements
o Performs source document verification, retrieves Case Report Forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites
o Ensures Serious Adverse Event (SAE) reporting according to project specifications
o Responds to requests from investigative sites in a timely fashion
Mentors junior level CRAs and serves as a resource for new employees
May serve as a resource for and interact with other functional areas to resolve site issues and facilitate project timelines
If assigned direct reports: Schedules and reviews project tasks, provides leadership in the delivery of services to clients, ensures that staff fulfill their responsibilities in accordance with PRA s policies, procedures, and SOPs, and ensures HR processes are properly implemented
May be assigned Lead CRA accountabilities on non-global studies
QUALIFICATIONS
Undergraduate degree in a clinical, scientific, or related field or its international equivalent, or equivalent work experience required
An advanced degree (e.g., M.S., M.B.A., PharmD, etc) preferred
Read, write and speak fluent English; fluent in host country language
Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail preferred
Knowledge of ICH and local regulatory authority regulations regarding drug research and development preferred for CRA 1; required for CRA 2 and 3
Clinical research employment experience required for CRA 1, 2, and 3. Must have at least one year of monitoring experience to apply.
Applicant Category: Professional
Requisition Code: Work at home
Two Initials of Recruiter: bw
System Date: 02/23/2007
System Time: 09:23:20
Document Name(40): Clinical Research Associate - Home Based
Source: HireHealth - USA
SearchTerms: "work at home" "work from home"
URL(80): http://www.hirehealth.com/Public/JobDetails.aspx?JOB_ID=187197&srch=%22work+at+h
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