Clinical Trial Associate II (DOCs)
ICON Clinical Research - United States

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Clinical Trial Associate II (DOCs) - 003170 Description
      Clinical Trial Associate II

      This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

      Overview of the Role · Utilizes technology effectively to support the Clinical Discovery development process.
      · Proficient use of the Impact system at the Protocol, Country and Site level.
      · Proficient use of other applications and software (Study Management Tools, Excel, PowerPoint, Electronic Study File, eConferencing, Prism, Net Calendar, etc.) to support the processes and project teams.
      · Manages multiple tasks during the study start-up process. Coordinates essential study documentation and tracking of expiration dates (e.g., IRB/EC approvals, regulatory documentation, CV's, financial disclosures, laboratory certifications etc.) and site supplies (e.g., CRF's, drug supply coordination).
      · Utilizes strong organizational skills to manage study documentation and supplies during all phases of the protocol execution (start-up, maintenance and study closure).
      · Prepares, distributes, collects and tracks relevant documents and study supplies. Responds proactively to site supply needs. Independently follows-up and resolves outstanding issues.
      · Demonstrates a general understanding of the key steps in the clinical research process, assists the Clinical Scientist with the coordination of the planning, implementation and administration of CD projects in accordance with established timelines and applicable project standards and standard operating procedures.
      · Interacts effectively with a wide range of individuals, collaborates effectively with internal groups and individuals to achieve key deliverables.
      · Assists in the preparation of Protocols, Clinical Study Reports, Annual Report updates and other project related documents.
      · Communicates effectively using excellent verbal and written skills; coordinates information and document flow to and from internal and external vendors (e.g., safety updates, amendments, administrative letters, contracts etc.).
      · Works well in a team environment by employing excellent interpersonal skills and demonstrates a "can do" approach in supporting the efforts of the Clinical Discovery Teams.
      · Exhibits professionalism and strong business ethics by maintaining confidentiality where appropriate, exhibiting candor and honesty with co-workers, and respecting Company policy and privileges.
      · Works well with little or no supervision by demonstrating the ability to think in a logical, decisive manner.
      · Utilizes effective problem-solving approaches.
      · Exhibits flexibility and willingness to develop new skills by being receptive to new systems and processes.
      · Seeks to identify best practices within established processes. Openness to change.
      · Ability to act as a mentor and resource guide to newly hired Clinical Trial Associate's to help them learn the BMS processes, systems and procedures.
      Role Requirements / Skills / Experience Required · Experiences in study and site associated document management processes. Able to organize and track documents associated with protocol packages, clinical trial packages, IRB information, etc. with various projects.
      · Experience working in a team environment and with a variety of people.
      · Experience working in a heavily-matrixed environment; navigating and networking with individuals to accomplish tasks.
      · Experience in accomplishing tasks within a timeframe; obtaining the necessary resources to achieve goals.
      · Strong understanding of the development process as it relates to the execution of clinical trials with a focus on document workflow associated with study and site startup to study closeout.
      · In-depth knowledge of software and web-based applications.
      · Excellent verbal and written communication skills.
      · Moderate understanding of International Conference on Harmonization (ICH), and Good Clinical Practices (GCP) guidelines and local regulations as they apply.
      We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
      In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON.
      What’s Next

      Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.

      Job : Clinical Project manager
      Primary Location : US-Any US location

      Organization : Project Management

      Job Posting : 28/Feb/13, 4:37:54 PM

      ICON Clinical Research - 13 months ago - save job - block
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      Contract research organization (CRO) ICON is not iconic yet, but it would like to be. By the time a new drug hits the market, it has passed...