Clinical Research Specialist IV

Mansfield, MA

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Clinical Research Specialist IV in Mansfield, Massachusetts. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity

RESPONSIBILITIES

  • Collaborate (writing, reviewing, editing, approval) with stakeholders from clinical, R&D, quality and regulatory teams on clinical evaluation reports (CER), clinical impact assessments, post market surveillance reports, and other documents that require the evaluation of clinical data and/or clinical literature
  • Conduct proofreading, editing, document formatting, review comment integration and document completion/approval activities
  • Work with other functional groups (marketing, R&D, regulatory) to identify competitor devices and to understand state-of-the-art for the therapy area and product line
  • Develop and maintain therapeutic and device operation knowledge literature required to support identified product lines and related clinical studies, stay informed about applicable clinical landscapes and trends; apply this knowledge to the development of well-written, clear and concise reports
  • Work with the librarian(s) and other data retrieval specialists to develop literature or data search strategies
  • Actively participate, review and give input into development of post-marketing surveillance (PMS) and post-marketing clinical follow up (PMCF) plan
  • Actively participate, reviews and gives input into developing or updating risk assessments
  • Develop and maintain in-depth knowledge of clinical evaluation best practices and regulatory agencies guidelines on clinical evaluation requirements
  • Provide subject matter expertise to ensure on-time completion of Clinical Evaluation Reports (CER) to substantiate the safety and performance of assigned medical devices in order to support product launches or recertification in various regions (may require working with other internal or contract medical writers)
  • Collaborate with Quality and other cross-functional partners to develop comprehensive risk documentation, such as; Risk Management Plan, Product Risk Assessment, Failure Modes and Effects Analysis (FMEA), Risk Management Report, and Post Launch Risk Management Review

EXPERIENCE

  • 3 years’ experience in medical device/drug clinical research required
  • Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), or Good Manufacturing Procedures (GMP) is preferred
  • Ability to appropriately apply different standards related to medical devices/ clinical research (SOPs, GCP, ISO, ICH, FDA, MedDev, etc.) as needed
  • Effectively written, verbal and presentation skills in the area of technical/clinical applications. Strong medical, technical or clinical background required. Strong command of medical and surgical terminology
  • Experience with Good Clinical Practice (GCP)  

EDUCATION

  • A minimum of an Associate’s degree (Life Sciences strongly preferred - Animal Science, Biology, Physiology, Nursing, or Medical Technology)
  • Bachelor’s degree preferred

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 resources

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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