Job Listing: Clinical Trials Specialist

A World Wide Clinical Research Organization (CRO) is searching for a Clinical Trials Specialist in the Research Triangle Park of North Carolina.

Job Description:
The Purpose of the Site Start Up Specialist position is to provide all necessary support in identifying and selecting investigators, and in completing the collation of all required documentation necessary so that investigational product can be shipped to sites in advance of patient enrollment in a given trial. This position is developing a strong understanding and command of the basic skills necessary for the application of regulatory requirements, contractual/budgetary guidelines, and CRO SOPs/Work Instructions to assigned responsibilities.

Responsibilities Include the following:
-Identifying Investigators
-Assisting Clinical Trial Leaders and Project Managers (PM) with the selection of investigators, and work with investigative sites and ad-hoc team members to complete all documentation necessary so that investigational product can be shipped to sites in advance of patient enrollment in a given trial.
-Negotiating and budgeting Site contracts
-Serve as a central contact for designated project reports, communications/correspondence, and associated documentation reviews and/or negotiates confidential disclosure agreements, regulatory documents, and contracts as required for site initiation
- Contacts sites as required to resolve issues
-Determines completeness and readiness for Clinical Supplies/Investigational Product Shipment
-Assists designated team members in preparing submissions for Independent Ethics Committees (IEC) or Institutional Review Boards (IRB) by compiling the Independent Ethics Committees (IEC) or Institutional Review Boards (IRB) by compiling the package of documents for IEC/IRB and forwarding it to either the Investigator or IEC/IRB as directed.
-Assists clinical teams in evaluating the investigators performance at closeout to facilitate future site identification activities.

Preferred Qualifications/Experience:
-1-2 plus years Clinical Research Coordinator (CRC) experience
-Associates or Bachelor's Degree in Health, Biological Science, or other related field, and 2 years related experience in health care field or other comparable combination of education, training and experience
-Basic knowledge and understanding of CRO clinical systems and procedures
-1-2 years hands on experience with regulatory documents including CRF's,ICF,FDA, and 1572's
-Possesses basic knowledge and understanding of applicable regulatory regulations
-Possesses good communication skills, both verbal and written
-Possesses good organizational skills
-Has a general working knowledge of clinical research
-Must be highly motivated
-Must be computer literate, including well developed computer skills in applicable software (eg. MS Word and Excel)
-Ability to utilize initiative and work independently as required
-Good at following instructions

NO RELOCATION ASSISTANCE AVAILABLE FOR THIS POSITION

Required Skills for Clinical Trials Specialist Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.