Clinical Research Associate

Cambridge, MA

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Research Associate in Cambridge, Massachusetts. The Clinical Research Associate will actively participate in a variety of activities to support and facilitate the efficient conduct of patient trials in clinical research programs.  Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 

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 
  • 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

EXPERIENCE

  • 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)

EDUCATION

  • Bachelors degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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