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.
TKL Research, Inc. - 2 years ago