Sr. Clinical Research Associate (Sr. CRA), Oncology- Massachusetts Job

Employer
Merck
Location
Boston, MA, US
Posted
October 12 2017
Organization Type
Pharma
Requisition ID: CLI005715

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.  Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Sr. CRA acts as primary site contact and site manager
throughout all phases of a clinical research study, taking overall responsibility
of allocated sites.




Duties and responsibilities include, but are not limited to
the following:



  • Develops strong site relationships and ensures continuity of
    site relationships through all phases of the trial.
  • Performs clinical study
    site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs,
    Local Laws & Regulations, Protocol, Site Monitoring Plan and associated
    documents.
  • Gains an in-depth understanding of the study protocol and related
    procedures.
  • Coordinates & manages various tasks in collaboration with
    other sponsor roles to achieve Site Ready.
  • Participates & provides inputs
    on site selection and validation activities. 
  • Performs remote and on-site
    monitoring & oversight activities using various tools to ensure:
    • Data
      generated at site are complete, accurate and unbiased 
    • Subjects’ right, safety
      and well-being are protected
  • Conducts site visits including but not limited
    to validation visits, initiation visits, monitoring visits, close-out visits
    and records clear, comprehensive and accurate visit & non-visit contact
    reports appropriately in a timely manner.
  • Collects, reviews, and monitors
    required regulatory documentation for study start-up, study maintenance and
    study close-out.
  • Communicates with Investigators and site staff on issues
    related to protocol conduct, recruitment, retention, protocol deviations,
    regulatory documentation, site audits/inspections and overall site performance.
  • Identifies, assesses and resolves site performance, quality or compliance
    problems and escalates per defined CRA Escalation Pathway as appropriate in
    collaboration with CRM, PLM and RCPM.
  • Manages and maintains information and
    documentation in CTMS, eTMF and various other systems as appropriate and per
    timelines.
  • Contributes strongly to CRA team knowledge by acting as process
    Subject Matter Expert (SME), sharing best practices, making recommendations for
    continuous improvement and providing training as appropriate/required.
  • Supports and/or leads audit/inspection activities as needed.
  • Mentors / buddies
    junior CRAs on process/study requirements and performs co-monitoring visits
    where appropriate
*This is a remote/Home-based position. 

Qualifications

Education:



  • Required:  BA/BS
  • Preferred:  BA/BS with
    strong emphasis in science and/or biology





Required:



  • Minimum of 4 years of direct site management (monitoring) experience in a
    Biopharmaceutical, Pharmaceutical or CRO company.
  • Experience monitoring Oncology clinical studies
  • Travel: 65%-75%
  • Valid driver's license









CORE Competency Expectations:



  • Fluent in Local Languages and
    English (verbal and written) and excellent communication skills, including the
    ability to understand and present technical information effectively.
  • Excellent understanding and
    working knowledge of clinical research, phases of clinical trials, current
    GCP/ICH & country clinical research law & guidelines.
  • Excellent understanding of
    Global, Country/Regional Clinical Research Guidelines and ability to work
    within these guidelines.
  • Demonstrated ability to
    mentor/lead
  • Hands on knowledge of Good
    Documentation Practices
  • Proven Skills in Site
    Management including independent management of site performance and patient
    recruitment
  • Demonstrated high level of
    monitoring skill with independent professional judgment.
  • Good IT skills (Use of MS
    office, use of various clinical IT applications on computer, tablet and mobile
    devices) and ability to adapt to new IT applications on various devices.
  • Ability to understand and
    analyze data/metrics and act appropriately



Behavioral Competency Expectations:



  • Effective time management,
    organizational and interpersonal skills, conflict management, problem solving
    skills
  • Able to work highly
    independently across multiple protocols, sites and therapy areas.
  • High sense of accountability
    / urgency. Ability to set priorities and handle multiple tasks simultaneously
    in a changing environment.
  • Works effectively in a matrix
    multicultural environment. Ability to establish and maintain culturally
    sensitive working relationships.
  • Demonstrates commitment to
    Customer focus.
  • Works with high quality and
    compliance mindset 

Our employees are the key to our company’s success.  We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.  Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.  If you need an accommodation for the application process please email us at staffingaadar@merck.com.
  
Search Firm Representatives Please Read Carefully: 
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
 
For more information about personal rights under Equal Employment Opportunity, visit:
 
            EEOC Poster
            EEOC GINA Supplement

HJ72017

Job: Clinical Research Monitor(CRA)
Other Locations:
Employee Status: Regular
Travel: Yes, 75 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck