| Job Description | Job Description
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.
We are seeking a highly motivated Clinical Research Coordinator for our growing organization!
In this role, you will be responsible for the coordination and management of clinical studies from preparation through study closeout.
Responsibilities include, but are not limited to:
· Reads, understands and follows Standard Operation Procedures (SOP’s) in coordinating studies
· Independently manages upcoming, ongoing and pending studies for which assigned
· Performs numerous clinical and non-clinical duties which may include the following:
· Logs and prepares study materials prior to study initiation
· Procures necessary supplies and maintains adequate inventories
· Assembles study files, paperwork, regulatory binders, schedules, etc.
· Prepares and packs products, files, materials, etc., for studies to be conducted at other TKL sites
· Maintains product and material inventories/records
· Provides training for staff based on study requirements
· Reviews the documentation of all data and information and assures that study files are complete and accurate
· Tabulates or transcribes data, as necessary, to fulfill study requirements
· Assures that all aspects of a study are completed properly and according to projected timelines
· Closes out study files once complete and files final reports
· Schedules doctors and clinical staff to studies, as needed
· Works with study monitors in all aspects of the study (e.g. IRB completion, data collection and correction, drug accountability, etc.)
· Reviews all data and information at study conclusion prior to computer data entry and report preparation
· Performs miscellaneous clinical and non-clinical duties upon request
· Prepares timelines for studies
· Works with Data Management, Stats, and Medical Writing, as appropriate for study protocol
· Mentors, trains, guides study team members on their roles and responsibilities.
· Miscellaneous duties, as necessary, in support of Research Clinical Division initiatives and TKL business priorities and objectives.
Skills & Requirements
Min Bachelor’s degree, preferably in the sciences or health related field. Ideal candidate will have at least 2 years relevant experience in the health sciences field and a minimum of 2 years of clinical trials experience in a lead position as acting coordinator. Clinical Research Professional Certification is preferred. Must possess knowledge of FDA regulations and GCP/ICH guidelines as they apply to the conduct of clinical research. Must have excellent written and verbal communication skills in order to effectively communicate to a wide variety of audiences including clinical subjects, sponsors, and internal staff. High level of facilitation skills is required in order to work with different types of team members. Working knowledge of Microsoft Office Suite is required. This is a full-time opportunity based primarily in our Fair Lawn, NJ facility.
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. |
| | Company | | TKL Research | Job Code | | State or Province | | New Jersey | | |
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