NewYorkRecruiter
the smart solution for New York jobs

Clinical Research Associate

Company: Advanced Clinical
Location: New York
Posted on: June 13, 2018

Job Description:

OVERVIEW

We are currently searching for a skilled professional to join a well-known clients team as Clinical Research Associate in New York, New York. The Clinical Research Associate role will contribute to the management and oversight of clinical trials while working closely with all R&D, Project Management, Regulatory Affairs and Pharmacovigilance team members. Their work will have a direct impact on not just the organization but also on the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES


  • Participate in the design of clinical trials and site-feasibility
  • Review trial documents including study protocols and amendments, patient information, informed consent forms, study manuals, monitoring plan, progress reports, and clinical trials reports
  • Create a comprehensive checklist of study requirements
  • Conduct pre-study visits and draft pre-study evaluation reports
  • Administer training to site personnel and evaluate the trial site and applicable personnel on an ongoing basis
  • Communicate with investigators and their staff, to ensure compliance with protocols, regulatory requirements, and good clinical practices
  • Perform on-site data verification, data integrity, and monitor CRF completion and queries using metrics standards
  • Write initiation visit and follow-up visit reports
  • Build appropriate intervention plan for the avoidance of redundant errors and/or deviations
  • Manage the integrity of investigator files, ensure accessibility of clinical and non-clinical materials, maintain the required documentation in the Trial Master File (according to company standards and applicable guidelines), and check for consistency with the contents of sponsor files
  • Verify compliance with procedures to apply if serious adverse events occur
  • Collaborate with investigators the obligations needed at the end of the study and write closure visit reports
  • Monitor clinical trial related budgets and resources allocation in collaboration with the clinical study managers
  • Anticipate, recognize and resolve issues proactively with the project team
  • Act as liaison between site personnel and the in-house clinical project team


    EXPERIENCE


    • Minimum 4 years of CRA experience in a pharmaceutical company or a CRO with on-site monitoring activities required
    • Oncology or nuclear medicine experience preferred
    • Strong understanding and experience in diagnostics, nuclear radioactive compounds required
    • Imaging experience required
    • Comprehensive knowledge in clinical trial conduct in accordance with ICH/GCP and other clinical trial-related regulations/guidelines
    • Experience in coordinating collaboration amongst investigative centers, clinical staff, and CROs
    • Knowledge in EC & CAs submission preparation
    • Working knowledge in EDC and CTMS systems
    • Experience in contract negotiation is preferred


      EDUCATION


      • Minimum of Bachelors Degree in Life Sciences required


        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. Youre 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, youre 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 Tribunes Top Workplaces, Chicagos 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.

          Keywords: Advanced Clinical, New York, Clinical Research Associate, Healthcare, New York, New York

          Click here to apply!

          Didn't find what you're looking for? Search again!


          I'm looking for
          in category
          within


Other Healthcare Jobs


Health benefit recruiter
Description: 1 Leading Health Care Provider Company is searching for Health Representatives that are looking to work FROM HOME Our company has been in business for 22 years with well over 2 million satisfied
Company: M lagace enterprise
Location: Staten Island
Posted on: 06/18/2018

Urgent Care Physician Assistant - Barton Associates
Description: Job Benefits --- Competitive compensation --- Travel-related expenses covered --- A-rated medical malpractice
Company: Barton Associates
Location: New York
Posted on: 06/18/2018

Registered Nurse (RN) - No Experience Necessary! - Located in Yuma, AZ
Description: Yuma Regional Medical Center offers fulfilling careers in a state-of-the-art medical facility surrounded by a
Company: Yuma Regional Medical Center
Location: Jersey City
Posted on: 06/19/2018


Neonatal-Perinatal Nurse Practitioner (New Hyde Park,NY)
Description: Neonatal-Perinatal Nurse Practitioner New Hyde Park,NY Locum tenens opportunity
Company: LocumTenens.com
Location: New Hyde Park
Posted on: 06/18/2018

Vascular Ultrasound Technician Jobs
Description: Travel Vascular Ultrasound Technician Numerous Nationwide Travel Assignments / Jobs br br Tired of completing an application just to get informationClick the View or Apply button for HCEN's Free, (more...)
Company: Travel HealthCare Jobs
Location: Jersey City
Posted on: 06/18/2018

Adult Psychiatrist (Newark,NJ)
Description: Adult Psychiatrist Newark,NJ Partial hospitalization program in New Jersey
Company: LocumTenens.com
Location: Newark
Posted on: 06/18/2018

Labor & Delivery Nurse - Travel - Travel (LD RN)
Description: Superior facility with exclusive travel opportunities br This prestigious New York Hospital is ranked among the top hospitals
Company: American Mobile Healthcare
Location: New York
Posted on: 06/18/2018

Locum Tenens Adult Inpatient Psychiatrist (Ridgewood,NY)
Description: Locum Tenens Adult Inpatient Psychiatrist Ridgewood,NY A facility in upstate New York is seeking a locum
Company: LocumTenens.com
Location: Ridgewood
Posted on: 06/18/2018

Locum Tenens Psychiatrist (Astoria,NY)
Description: Locum Tenens Psychiatrist Astoria,NY Outpatient mental health clinic in upstate New York is currently seeking a part-time
Company: LocumTenens.com
Location: Astoria
Posted on: 06/18/2018

PICU RN Needed For A 13 Week Contract
Description: Skyline Med Staff is looking for some of the most talented nurses in the industry to fill
Company: Skyline Med Staff
Location: Paterson
Posted on: 06/18/2018

Log In or Create An Account

Username:
Password:
 

Forgot password?


Find us on Facebook

Find us on LinkedIn

Get the latest New York jobs by following @recnetNY on Twitter!

New York RSS job feeds