Sr Clinical Site Monitor (Sr. Clinical Research Associate) - Dallas,TX
Location:
Dallas , Texas
Posted:
November 17, 2016
Reference:
1604818
This position is located in either Oklahoma City, Oklahoma, the surrounding area or Tulsa, Oklahoma and the surrounding area. Clinical trial sites are located primarily in Oklahoma but position will require 10-15% travel to monitor sites in Dallas, Tx, St.Louis, Mo. and Kansas if needed.

Position description:
  • Serve as the site facing role for clinical operations at sites within a region.
  • Expedites the pre-study and study initiation processes including conduct of Pre-Study Evaluation and Site Initiation Visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.
  • Identified, evaluates and recommends potential investigators/sites on an on-going basis within assigned region.
  • Critically reviews and analyzes site activities through targeted risk based site contacts and on-site visits to monitor study sites protocol execution and compliance to applicable BMS SOPS, subject protection and ICH and/or FDA GCP Guidelines and other local regulations. This includes but is not limited to: Managed multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and or/geographic territory. Significant travel outside of region is rare.
  • Ensures timely entry and quality of data submitted from study sites.
  • Supervises overall activities of site personnel’s study conduct and motivates and influences site personnel to meet study and timeline objectives.
  • Anticipates and proactively resolves study site issues using critical thinking skills. This includes the ability to conduct root cause analysis, implementing corrective actions, ensuring appropriate preventative actions are developed, implemented and being followed and finally the ability to demonstrate via verbal and written methods the process or “story” of the issue.
  • Ensures documented follow-up to all outstanding issues within monitoring management system ensuring appropriate issue escalation to line manager and project team members as necessary.
  • Facilitates, as needed, internal regulatory compliance audits and Health Authority inspections for assigned sites.
  • Provides monitoring assistance to site monitor colleagues within and outside of region to ensure timely execution of deliverables.
  • As a Sr. Site Monitor, serves as the example of professionalism, collaboration and efficient execution of deliverables, including mentoring others.
  • Proactively communicates and escalates with all internal and external stakeholders any significant issues identified at study sites while developing corresponding mitigation strategies and solutions.
  • Prepares and submits monitoring and management reports in a timely, accurate, concise and objective manner.
  • Initiates, develops and grows professional and collaborative relationships with internal/external study personnel and necessary institution stakeholders.
  • Effectively prioritizes time in order to meet deadlines, goals, and action
  • Passionately utilizes critical thinking skills and embraces change (effective change agent) for systems, processes, tools
  • Observe site/CRO relationships and communicate / connect with internal stakeholders to meet BMS study goals and/or milestones. Be a BMS/site level advocate to ensure impact on issues do not include significant concerns without necessarily resolving the issue directly.
  • Effectively demonstrates leadership and people development (mentoring, shares knowledge, improves performance via coaching and feedback)
  • Demonstrates ability to adapt complex verbal and written information into concise messages
  • Builds, cultivates, and maintains customer relationships and identifies synergies between customer needs and the company’s interests



Qualifications:
  • .
  • 10 years of pharmaceutical development experience with at least 5 years of advanced site monitoring/management in complex small molecule and biologic trials specifically oncology trials as well as across the development spectrum (phase I-IV).
  • Mastery of all site monitoring visits (pre-post) while also understanding that site personnel may require support until lock
  • At minimum a Bachelor of Arts or Science, or equivalent, in health related field from an accredited institution.
  • Extensive knowledge of ICH/FDA guidelines and thorough knowledge of global Health Authority (e.g., EMA, MHRA) regulations impacting activities in the US.
  • Thorough technical working knowledge of Remote Data Capture, EMR and computer based systems.
  • Thorough knowledge, experience preferred, of industry trends (Risk Based Monitoring, Remote Monitoring, Remote Source Data Verification/Review, etc.)
  • Ability to resolve a majority of complex study/site related issues independently using functional expertise while exercising excellent judgment and decision making skills.
  • Exhibits a high level of flexibility and sets an example for adaptability for changing priorities and processes.
  • Employs strong fiscal management of departmental budget by independently managing travel and functional expenses.
  • Identifies innovative solutions to accomplish objectives while maximizing utilization of budget, resources and time.
  • Demonstrates strong project management skills when engaging with stakeholders to ensure efficient management of timelines, resources, encountered challenges and stakeholders.
  • Serves a role model for department through active planning, participation and representation on various projects, initiatives involving a wide breadth of internal and external stakeholders.
  • Ability to manage successfully with designated book of work, adjust accordingly for risk based monitoring practices using critical thinking skills, and prioritize actionable items, make appropriate decisions as well as action plans
  • Effective communication skills (emotional intelligence, verbal cues, non-verbal cues, adapting for audience, and listening to create openness and trust).
  • As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of "Qualified Driver," as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver's license in good standing issued by your state of residence; and, 3) a driving risk level deemed acceptable by the Company.
A little about us:
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