20 Oct

Cra Jobs Vacancy in Quintiles Transnational Mumbai

Position
Cra
Company
Quintiles Transnational
Location
Mumbai MH
Opening
20 Oct, 2018 30+ days ago

Quintiles Transnational Mumbai urgently required following position for Cra. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Cra Jobs Vacancy in Quintiles Transnational Mumbai Jobs Details:

PURPOSE
Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. If applicable, Clinical Research Associates may be accountable for development of project subject recruitment plan on a per site basis. Support work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
RESPONSIBILITIES
 Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
 If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
 Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
 Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
 Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
 Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
 Build awareness of features and opportunities of study to site.
 Collaborate and liaise with study team members for project execution support as appropriate.
All responsibilities are essential to job functions unless noted as non-essential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
 Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
 Good therapeutic and protocol knowledge as provided in company training
 Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a lap top computer
 Good written and verbal communication skills including good command of English language
 Good organizational and problem-solving skills
 Effective time management skills
 Ability to establish and maintain effective working relationships with coworkers, managers and clients



Qualifications

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
 Bachelor's degree in a health care or other scientific discipline or educational equivalent and successful completion of a CRA Trainee Program or 3+ months of on-site monitoring experience; or equivalent combination of education, training and experience.
PHYSICAL REQUIREMENTS
 Extensive use of telephone and face-to-face communication requiring accurate perception of speech
 Extensive use of keyboard requiring repetitive motion of fingers
 Regular sitting for extended periods of time
 Requires frequent travel to sites



Did You Know?
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!


We invite you to join IQVIA™.


Primary Location: IND-Maharashtra-Mumbai

Organization: IND02 - India - CDS/Product Devel

Job: Monitoring


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