Clinical Trials Associate
TKL Research, Inc. - Rochelle Park, NJ

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TKL Research is a full-service, international Clinical Research Organization (CRO) serving the pharmaceutical, biotechnology, medical device and consumer healthcare industries. We provide comprehensive clinical trial management services for Phase 1-4 clinical research studies, including an inpatient Phase 1 facility and outpatient specialized research clinics.

As a Clinical Trials Associate, you will assist Clinical Project Managers with the conduct of multicenter clinical trials, primarily in administering the flow of documentation and reports.

Responsibilities include, but are not limited to:
Communicate with the project team

Communicate with sites on issues escalated by monitor and or the CRA Manager

Develop standard study logs and study tracking forms

Prepare materials (i.e., binders, presentations) for investigator meetings

Attend Investigator Meetings

Develop Status Reports under supervision of Project Manager

Prepare newsletters, if applicable, and distribute to sites and Sponsor

Attend team meetings

Expand on the information obtained from Investigator Feasibility needed to qualify a site

Miscellaneous duties, as necessary, in support of Clinical Project Management initiatives and TKL business priorities and objectives

Train entry level personnel in the following tasks:
Order clinical supplies and distribute to sites

Prepare, review and approve site regulatory documents

Prepare IRB submissions

Communicate with the IRB re: submissions

Track IRB approvals

Forward regulatory packets to Sponsor

Maintain Master file

Prepare study regulatory binders and distribute to sites

Min Bachelor’s degree, preferably in the sciences or health related field. The ideal candidate will have 2 years of clinical trials experience with a clinical research organization. General office skills, strong computer proficiency with MS Office, strong organization skills, detail orientation and good communication skills are required.

We offer a competitive compensation package for full time employees, commensurate with your background and experience, including full benefits, 401(k) with match and a profit sharing plan.

This is a full-time position based in our Rochelle Park, NJ headquarters.