Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers.  We currently have an exciting contract opportunity for a Clinical Trial Assistant for our client in East Hanover, NJ.

The Clinical Trial Assistant (CTA) will assist in the operational and logistical aspects of clinical trials according to GCP (Good Clinical Practice) and relevant company procedures and assist in delegated tasks to support the clinical trial team, ensuring that all essential documentation is collected, maintained and filed during the study.

This individual will provide support to the Clinical Trial Leader (CTL) with many of the tasks involved with the smooth running of clinical trials in compliance with company processes.  He/she will collaborate with the CTL in taking action to address issues as they arise. 

The CTA will help manage clinical, regulatory and study related essential documents such as study protocols, Case Report Forms, Informed Consent Forms etc.; review documents for completeness, accuracy and compliance with protocol and appropriate regulations. He/she will identify issues and take appropriate corrective action as necessary.  Other responsibilities include:

• Interactions with Investigator sites (e.g. to collect relevant documentation, provision of study materials / documents.)
• Liaise with contract organizations, vendors and other suppliers of project support services to ensure study deliverables are met (e.g. contribute to documentation, processes and set up activities to facilitate efficient working and effective partnerships with external groups.)
• Provide input on agendas, create materials, liaise with meeting planners and coordinate logistics for key meetings (e.g. internal CTL meetings or external investigator meetings.) May attend and present at these meetings, as appropriate.
• Help ensure accuracy of clinical trial management databases and resource/budget tracking tools, providing information, maintaining meeting minutes and following up on questions as necessary. Help check for discrepancies and take actions to correct as necessary.
• Identify areas for process or technology improvements with regard to tasks undertaken within the role.
• Assist in the ordering of clinical trial supplies.
  Assist in the compilation of the clinical study report and its
• appendices.
• Set up and maintain Trial Master Files and ensuring all relevant study documents are filed and archived based on the appropriate guidelines.
• Assist the CTL in organizing Investigator/Site Initiation Meetings and/or First Dose/Monitoring Visits.  Attend at least 1 of these meetings and assist the CTL in conducting.
• Maintenance of knowledge and training of ICH GCP, current regulations and procedures.

SKILLS
In order to be successful within this role, qualified candidates should be computer literate and have good organizational and interpersonal skills.  The ability to work in a team as well as independently, if required, and to manage multiple priorities, with support, is required.

EDUCATION/EXPERIENCE
Qualified candidates should have a Bachelors degree or equivalent with at least 1 year of Life Science or Nursing experience.  Previous working experience within Clinical Trials (i.e. clinical trial design, execution and operations) is preferred.

If you meet the qualifications and requirements for this position, please Apply Now. Qualified candidates will be contacted.

Kelly Scientific Resources has grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities.  We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com.

Kelly Services is an Equal Opportunity Employer.