Clinical Regulatory Affairs Career Research and Resources
Aeras
This was a period of time were a surge of phase I clinical trials for different vaccines candidates primarily Aeras 402 and 404 were starting domestically (Lenexa, Kansas) and globally. I did extensive preparation and traveling to present information at study initiation visits (SIV) at the Walter Reed Research in Kondele/Kambewa Kenya, SATVI in Worcester/Cape Town South Africa, vaccine Research Center/University Tampere Fin...
Avg. Salary: $0 · Company Rank: Not Available
Aeras
As an organization in start-up phase, my role included a great variety of activities geared towards preparation of vaccine clinical trials and epidemiological studies. These activities included the identification, sourcing and validation of a specimen management system and cryoshipping equipment to be used for the domestic and global transport of temperature sensitive cells in preparation for phase I clinical trials for our...
Avg. Salary: $0 · Company Rank: Not Available
Covance Laboratories, Inc.
I became supervisor after six months as research associate. This position involved more responsibility that I welcomed as I had gained the team's trust in my previous role. I had a more active role with the analytical chemistry team and study direction in the planning and timely start of client studies taking into account their busy schedules. The evaluation and revision of metrics for each study were performed as well as ...
Avg. Salary: $0 · Company Rank: Not Available
Covance Laboratories, Inc.
I quickly learned the department's fit and operation within the Mammalian Toxicology department, its main responsibilities and who were the primary stakeholders benefiting from my work. Having a background as lead formulator I became a technical expert on many types of formulation preparations and was able to carry out all aspects of the studies under strict GLP compliance. Was able to organize and evaluate self generated...
Avg. Salary: $0 · Company Rank: Not Available
Western Institutional Review Board
Responsible for increased usage of services by existing clients and capture of new customers for expanded service offerings within an assigned territory. Analyzed prior revenue metrics with BD team and executive management to determine targeted revenue growth for up-coming year and establish defined regions or client sectors. Goals were to initiate dialog and schedule meetings for services presentations with client decisio...
Avg. Salary: $69,000 · Company Rank: Not Available
Western Institutional Review Board
Responsibilities: the establishment and maintenance of relationships at the executive level with potential, former and current clients through systematic out-reach via teleconferences, web and in-person meetings. Served as an escalation point of contact for all significant client concerns, worked within cross-functional teams to resolve issues within agreed upon conditions. I prepared proposals for new business with new and...
Avg. Salary: $69,000 · Company Rank: Not Available
Western Institutional Review Board
Support the New Business & Development Department with client relationship management and new business development. Development of new business was achieved through a variety of methods, including cold calling, responding to in-bound inquiries, attendance and networking at trades shows and conferences. Provide feedback information regarding clients' organization, culture, technical needs and strategic objectives to manageme...
Avg. Salary: $69,000 · Company Rank: Not Available
Western Institutional Review Board
Managed the daily activities of outward facing client service and project management teams, ensuring the quality and timeliness of all external communications to clients. Responsible for the overall direction of the departments that provide client support . Served as the escalation contact for clients while acting as a liaison to internal teams to ensure effective communication of expectations. Implemented training and perf...
Avg. Salary: $69,000 · Company Rank: Not Available
Western Institutional Review Board
Managed daily operations of a diverse division comprised of four departments, 4 supervisors, 52 operational staff. Responsible for generation and adherence to division budget, development of new procedures, processes, policy and standard operating procedures as well as all hiring, firing, training, mentoring and evaluation of staff. Routinely managed budget under 4% of proposed
Avg. Salary: $69,000 · Company Rank: Not Available
Western Institutional Review Board
Supervised 9 staff that handled all in-bound communications, primarily telephone but also fax and e-mail. Additionally this team researched and processed all corrections to regulatory documents released by the production teams to clients. Responsible for hiring, firing and training for both client interactions, research subject calls and the analysis of errors and processing corrections to documentation
Avg. Salary: $69,000 · Company Rank: Not Available
