Clinical Research Assoc - Data Assistance

Arthrex, Inc. Naples, FL
Job Description

Requisition ID:

41235

Title:

Clinical Research Assoc - Data Assistance

Division:

Arthrex, Inc.

Location:

INC- Naples, FL

Main Objective:

Assists the study team in running the day to day operational activities of clinical studies. Assist in the development and maintenance of Electronic Trial Master File (eTMF) and Electronic Data Capture (EDC).

Essential Duties and Responsibilities:

* Responsible for establishing and maintaining Electronic Trial Master filing systems, securing essential documents and monitoring files and databases for accuracy and completeness.

* Responsible to perform clerical functions, maintain office / study supplies and equipment, and scanning and electronic filing.

* Responsible for establishing accounts in billing systems within compliance guidelines and issuing payments to vendors and investigators according to executed agreements.

* Works closely with management to review and get approval of clinical trial agreements and site specific budgets.

* Tracks study status, enrollment, regulatory documentation and site start up status.

* Assists in ordering, distributing and receiving investigational product.

* Assists in user acceptance testing and evaluating new upgrades.

* Assists with the preparation of technical reports, summaries, templates and protocols.

* Supplying sites with study binders and assisting study team in developing source worksheets

* Distributes updates to study sites.

* Records, compiles and distributes minutes from team meetings.

* Maintains all pertinent study correspondences between the sponsor, study sites and third parties.

* Assists with review and completion of study standard operating procedures and work instructions

* Coordinates Investigational site training monthly forums, meetings and newsletters

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

Associate's Degree required, bachelors degree preferred.

One year clinical research experience required.

Pre-market study experience preferred.

Sponsor or CRO experience preferred

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Knowledge of ICH guidelines and FDA Regulations relevant to clinical studies is required. Clinical Research Certification is preferred.

Comprehension of medical terminology, or can reference literature for understanding. Proficient software skills: Word/ Excel/ Power Point/database /bibliography programs.

Machine, Tools, and/or Equipment Skills:

PC, database, research tools, internet research tools.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.