Clinical Monitoring Associate I

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POST DATE 9/11/2016
END DATE 11/6/2016

PAREXEL San Diego, CA

Company
PAREXEL
Job Classification
Full Time
Company Ref #
post-00023995
AJE Ref #
576138199
Location
San Diego, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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Clinical Monitoring Associates -Program Overview:Join us at PAREXEL and launch your career in Clinical Research Services!Outstanding opportunity for recent life sciences graduates at PAREXEL! We are looking for qualified candidates interested in becoming Clinical Monitoring Associates in our San Diego office. Candidates selected will join PAREXEL in January 2017 and then attend a training and development program that will help our junior talent become prepared for a rewarding and challenging careerexperience with PAREXEL. The curriculum is marked by rich modules in the following areas: PAREXEL's Clinical Research Mission, Business Unit Goals, Client and Business Expectations; Understanding your Roles & Responsibility; Fundamentals of Clinical Research, including ICH-GCP, and dedicated time with experienced CMA's. The program is geared towards providing you with a functionalon-boarding integrated approach to understand our People, Process, and Technology. Our goal is to help you then progress to a Clinical Research Associate between 12-18 months.Specific Duties:Assume the ability to meet the requirements of a CMA I with a high degree of proficiency and autonomy - Take responsibility for specific tasks on projects, or acts as the main CMA contact on individual projects - Collaborate with CRA on site issues/actions - Create and distribute study document (e.g. eSignature Agreement, Amendments, etc.) - Initial and ongoing drug / supply management - Responsible for the completeness and quality of the in-house site specific files - Update all relevant tracking system on an ongoing basis - Maintain site staff details - Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS, ISIS) - Conduct remote visits (initiation, monitoring, termination) - Collect updated/amended regulatory documents in collaboration with CRA and CTS as needed - Primary in-house site support - On a regular basis conduct outbound and receive inbound calls to: - Review recruitment plan and enrolment updates - address/resolve issues pending from the previous visit - address protocol questions - check on site staff assignment - assess drug/study supply status - request outstanding documents - review site payment status - follow-up on data entry, query status and SAEs - Follow-up on appropriate site related questions - Build relationships with investigators and site staff remotely - Keep manager informed about work progress and any issues to avoid surprises. Position requires some interaction / supervision by Manager or assigned mentor - Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOP and stud specific procedure (e.g. Monitoring Plan) - Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics)QualificationsCandidates should have a strong desire to begin a career in Clinical Research, and have a four year degree in Life Sciences, Clinical Research, Nursing or Pharmaceutical Sciences. These positions are office based in San Diego and then will require traveling up to 75% of them time as you progress with your career. We are seeking candidates who have the ability to learn quickly, communicate effectively and see the big picture. If you are organized, have strong attention to detail, are able to build lasting relationships with clients, and demonstrate excellent communication skills - we want you to be a new member of the PAREXEL team.Strong computer skills including MS-Office products such as Excel, Word are required - Strong awareness of all relevant regulations, including GCP - Ability to successfully work in a virtual team environment - Basic knowledge of clinical research process - Analytical skills - Sound interpersonal, oral and written communication skills - Sound problem solving skills - Strong customer focus, ability to interact professionally within a client organization - Ability to prioritize multiple tasks and achieve project timelines - Sense of urgency in completing assigned tasks - Attention to detail - Effective time management in order to meet daily metrics or team objectives -Ability to produce consistently high quality work -Seek opportunities to develop experience and knowledge - Must be able to work independently but seek guidance when necessary, escalating issues as required - Willing and able to travel as required - Language Skills - Competent in written and oral English - Prior clinical, data management and/ or research experience with basic understanding of clinical trials methodology and terminology a plus Educated to degree level (biological science, pharmacy or other health-related discipline preferred), nursing or Clinical Research. Ability to successfully work in a team environment and display Client focused approach to work Excellent written and spoken English EEO DisclaimerPAREXEL complies with all applicable federal, state, and local laws prohibiting discrimination in employment. All qualified applicants will receive consideration for employment without regard to gender, age, race, color, religious creed, marital status, sexual orientation, national origin, ethnicity, ancestry, citizenship, genetic information, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
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