Kelly Services Clinical Research Associate in Cambridge, Massachusetts

Clinical Research Associate, Cambridge, MA

Kelly Services is seeking a contract Clinical Research Associate for one of our top clients in Cambridge, MA.

Duration : ASAP – 12/22/2017

Type : Contract

Hours : 40 hrs/wk, 8am-5pm

Responsibilities

  • Participation in the evaluation of clinical trial site locations.

  • Serving as the sponsor liaison to clinical sites during the activation process, as the study progresses, and during study close-out.

  • Traveling to sites as necessary to conduct site qualification, initiation, and close-out (<10%).

  • Collecting and managing regulatory documentation, to ensure compliance with GCP, ICH, regulatory authority, and ethics board requirements.

  • Working with clinical site staff and investigators to obtain study data, ensure protocol compliance, and guarantee patient safety.

  • Ensuring accurate and timely reporting of patient safety issues according to all relevant local and federal requirements.

  • Participating in regional and global conference calls and meetings to review progress of ongoing clinical trials.

  • Reviewing incoming clinical data, and preparing reports and presentations on the status of clinical studies.

  • Helping to draft study manuals and protocol amendments as needed.

  • Organizing and distributing study supplies and study-related documentation required for conduct of clinical trials.

  • Coordinating the movement of laboratory samples between clinical sites and central laboratories, and tracking the status of samples and resulting laboratory data.

Requirements

  • Bachelor’s degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field

  • 2-5 years of clinical research experience in industry settings; oncology experience strongly preferred

  • Knowledge of clinical trial methodology as well as the drug research and development process

  • Knowledge of GCP/ICH Guidelines for clinical studies

  • Ability to work independently and take initiative in a fast-paced work environment

  • Strong attention to detail

  • Strong organizational and communication skills

  • Excellent verbal and written communication skills

  • Competent computer skills including Microsoft Office

  • Familiarity with EDC systems (i.e. Oracle)

If you are interested in the position, please apply to this posting with an updated resume. Thank you for your time and I look forward to working with you.

Lauren Rogers, Kelly Services Scientific Recruiter

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm