Senior Clinical Trials Assistant Required @ Quintiles

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant. Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.

Post : Senior Clinical Trials Assistant

Job Description
PURPOSE
Provide administrative support to clinical projects with minimal supervision from line manager, Clinical Team Leads and/or other designated clinical team members. May assist with general administrative functions as required.
RESPONSIBILITIES
• Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
• Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.
• Collaborate with CTL on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• Assist in training and orienting new staff. May act as a mentor for less experienced CTAs.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
• May perform assigned administrative tasks to support team members with clinical trial execution.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• Knowledge of applicable protocol requirements as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Strong written and verbal communication skills including good command of English language
• Effective time management and organizational skills
• Attention to detail and accuracy in work
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

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Qualifications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
School diploma/certificate or educational equivalent; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS
•Extensive use of telephone and face-to-face interactions, which require accurate perception of speech
• Extensive keyboarding involving repetitive motions with fingers
• Regular sitting for extended periods of time
• Packaging and lifting supplies for storage and shipping
• Occasional travel

Additional Information:
Experience: 1-5 years
Location: Mumbai
Industry Type: Pharma
Functional Area: clinical projects