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Job Details

Senior Clinical Research Associate

Company: Chiltern
Location: Home-based Opportunities Anywhere in USA
Reference: LS - Sr. CRA
Closing Date: 15 Sep 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Home-based opportunities

Requirements:

Job Background

The Clinical Research Associate (CRA) is a key member of the Clinical Project Team and is responsible for managing investigator sites for selected studies. Incumbents monitor specified sites to ensure data integrity and compliance with Chiltern International or Client’s SOPs, ICH GCP and or ISO 14155, regulatory requirements and the project protocol. Incumbents are responsible for ensuring that projects are completed on time and within budget. 

1. Prepare and conduct site visits including (but not limited to): qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and close-out visits according to relevant SOPs, local requirements, the protocol and project plans as well as providing timely and comprehensive visit and status (i.e. patient recruitment) reports.


2. Communicate effectively with Chiltern Project Team members (i.e. Clinical Team Leader, Project Managers, Safety and Data Management) to ensure study completion per company and client requirements and timelines. Being a pro-active member in team calls and act as a role model. May support in the creation of CRA working tools based on the experience on the project.


3. Proactively communicate with study sites and follow-up on all open issues in order to meet the project timelines. Ensure that all study-related documentation is tracked, printed, and filed as required by Chiltern SOPs, regulatory requirements, and other protocols.


4. To ensure that investigator site files are assembled appropriately and that all required documentation is in place, tracked and reconciled on a regular basis against the TMF files.


5. May support in mentoring less experienced CRAs on project or department tasks and requirements.


6. May support in conducting quality control accompanied visits with CRAs level 1 or 2.
 

• BSc or BA degree in a biomedical or related life science, or nursing qualification
• Minimum 0 – 2 + years of previous CRA experience with single and/or multi-center trials, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
• to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors
• Demonstrated ability to conduct clinical operations activities effectively and efficiently with minimal supervision (for the starting period) of site activities and escalation procedures.
• Attention to detail
• Methodical approach to work
• Basic understanding of medical and clinical research terminology, and clinical research processes
• An understanding of the basics of physiology, pharmacology, and medical devices (when applicable)
• Understanding of the principles of ICH GCP, ISO 14155 (if applicable) and regulatory requirements
• Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications
• Good oral and written internal and external communication, team and organizational skills, personal presentation. The ability to communicate effectively in English.
• Experience using a clinical trial management system (CTMS)
• For medical device positions, experience in providing customer service to device end users
 



Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Salary

on application

Position Type

Permanent
Full Time

Contact

Email Lauren Sigmon - Lauren.Sigmon@Chiltern.com
+1 910 350 6730

Apply for this job: Senior Clinical Research Associate

Contact Information:

Address:  Wilmington, North Carolina, USA
2520 Independence Blvd, Suite 202, Wilmington, NC 28412, USA

USA
Tel:  +1 910 338 4760
Fax:  +1 888 301 2627
Website:  Visit Our Web Site

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