CRA Trainee, DP
Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 33,000 employees conducting business in over 100 countries. Today Quintiles brings a fully integrated approach to build biopharma and life sciences solutions – from pipeline to portfolio to population health. We apply the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit
www.quintiles.com
PURPOSE
Engage in company training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
RESPONSIBILITIES
Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
Gain experience in study procedures by working with experienced clinical staff in Clinical Research Associate (CRA), Clinical Research Specialist (CRS) and Clinical Trials Assist (CTA) roles. May also work collaboratively with other functional groups such as Data Management and Pharmacovigilance.
Under close supervision, perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.
Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
Under close supervision, 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 to Clinical Project Manager (CPM), CRS and/or line manager.
Under close supervision, 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.
Under close supervision, 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.
With the expansion of our clinical operations team, an opportunity has arisen for individuals to join Quintiles as a Trainee Clinical Research Associate and to become an integral part of our clinical operations team.
After an initial 16-week training period you will take on a role where you will monitor clinical trial sites for approximately 3-4 days per week, ensuring that visit reports are completed in a timely manner. You may cover any therapy area, and are likely to be working on more than one protocol at any one time. The role provides the opportunity to develop monitoring skills with advanced responsibilities, critical and central to the conduct of the clinical project. The CRA oversees the progress of a Clinical Trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements. This job requires scheduling flexibility and involves approximately 60-75% travel within a designated territory.
This role offers potential career progression within the clinical department, within an established career pathway and a comprehensive benefits package.
Qualifications
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
Good written and verbal communication skills including good command of English language
Basic organizational and problem-solving skills
Working time management skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM EDUCATION REQUIREMENTS
Four year University / College Degree in life sciences (biology, chemistry, physics, etc) or other related scientific disciplines (nursing, pharmacology, clinical research, etc).
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
Frequent travel to sites (65-70%), primarily domestic, may include international travel
We are seeking enthusiastic and motivated individuals who want to stretch themselves in an environment that encourages learning. Able to work independently, you will enjoy communicating with others as you will meet a variety of healthcare professionals at monitoring sites, and interact with teams at Quintiles.
APPLICATION INSTRUCTIONS
Visit quintiles.com/careers and apply online.
- Please note that this requisition is targeting candidates to start in the June 2016 cohort in RTP, NC and then serve the South Central region after the 12-14 week training period. The next cohort will start in September, 2016 and there will be separate requisitions posted for candidates to apply.
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Required application information – Requisitions expire on Thursday, March 24th for internal candidates, and Friday, April 1st for external candidates
1. Document Attachment – Please attach a resume to your application
a. Please be sure that your resume includes your cumulative GPA and graduation month and year.
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EEO Minorities/Females/Protected Veterans/Disabled
Primary Location
:
United States
Organization
:
USA02 – US Clinical Development Svcs
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