Speakers' Bureau Directory: Ball
|Degree:||Bachelors (BA or AB or BS)|
Bedford, Massachusetts 01730
|Primary Employer:||Other; Other Pre-Clinical Biocomp/Contract Research Organization|
|Scientific Specialty:||Biosafety; Other N/A|
|Job Title:||Study Director|
|Years in position:||4|
|Day to day responsibilities:
The role of a Study Director is to provide overall responsibility for the technical conduct of a study, as well for the interpretation, analysis, documentation, and reporting of results. Among other things this individual represents the single point of study control and ensures all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified. These actions are defined by Good Laboratory Practices (GLP), as described in the Code of Federal Regulations Title 21: Part 58, Section 33.
Duties pursuant to the above description include preparation of a governing experimental protocol and ensuring appropriate and applicable methodology is described therein. The protocol is typically established by industry guidance and a study director is familiar with the organizations and references that comprise these standards. These standards include but are not limited to: AAMI, AATCC, ASTM, CLSI, EPA, FDA, ISO, JIZ, & USP. In addition a study director must ensure proper training of technical staff and interface with associated departments such as Quality Assurance and Document Control.
At Toxikon, a Contract Research Organization (CRO), we provide pre-clinical biocompatibility, safety, and efficacy testing for Medical Device, Pharmaceutical, and Biotechnology Industries. As such a Study Director must be comfortable providing impartial scientific expertise and consulting services. Specifically, pre-clinical studies are often submitted as part of a larger document to the FDA wherein entities have applied for government approval to sell a product in the US medical market.
What do you love about your job?
Working at a CRO I get a first-hand look at future medical devices and pharmaceutical formulations. Toxikon is the industry leader in Biocompatibility services and this affords me a wide view on the movement of various industries as a whole. The environment here is always abuzz with activity and Toxikon fosters a strong collaborative environment; which serves to enhance my expertise and skill set. As someone with a background in antimicrobial drug discovery and R&D the study director role for me is the next logical step towards developing a comprehensive understanding for the process of taking an idea from conception to market. This career affords plenty of room for problem solving and the ability to consistently meet the testing needs of a client is a rewarding experience.
Degrees, experience, license(s), and skills required for position:
At a CRO the study director will often oversee multiple projects at any one time. Effective time management and organizational skills are required. The ability to train technical staff and interact with numerous other departments and client is essential. Professional membership to relevant industries and certification are important assets for establishing credibility. A degree in the sciences or engineering fields is necessary but a graduate degree is desirable. Participation in industry events such as conferences and workshops is important. Staying abreast of changes in regulatory and industry documents is critical to ensuring compliant study designs.
As it relates to microbiology a study director should be familiar with the following topics: Sterilization, Cleaning and Disinfection, Antimicrobial & Preservative Effectiveness, Ingress & Package Integrity, and Lot Release & Bioburden. These topics should be conformant to practices described in a typical validation program including statistical analysis, non-bias study design & review, and experimental controls.
Tips/Advice for how to secure a job in microbiology upon graduation:
My advice to anyone, regardless of education, is always be seeking to build your skill set and familiarity of the field. Most people will respond favorably to individuals who are enthusiastic and positive so it is important to find a career that fits your personality and interests. The most important skill you’ll ever need is the ability to network. I strongly advocate that undergraduates seek out a research project; even if it means volunteering. Take the time to participate and engage your peers and professors and leave a lasting impression. Don’t be afraid to ask questions. Finally, for people already seeking a career I always recommend reaching out and connecting with people active in your field of interest.