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Assoc Operations Specialist - NC in Durham, NC at Apex Life Sciences

Date Posted: 11/28/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/28/2018
  • Job ID:
    917688

Job Description


PURPOSE: 

  • Review, assess and process Drug Safety data and information, across all service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. 

RESPONSIBILITIES: 

  • Receive, triage, review and process data from various sources on time, within budget and meet quality standards.
  • Perform data entry for tracking and safety database, coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines.
  • Pre-process material for endpoint committee or core laboratory adjudication.
  • Preparation of material for submission of primary review.
  • Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement.
  • Liaise with local offices to facilitate expedited reporting.
  • Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data.
  • Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
  • Assist operations team with tasks, provide for back-up to the operations team, assist in generation of status reports, providing project metrics, drafting project instructions/guidelines and assist in implementation of new processes.
  • Contribute under guidance of senior staff to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information, or other service lines as appropriate.
  • Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
  • Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
  • May liaise with client in relation to details on day to day process of cases.
  • Perform operational and collaborative LSM task as directed by Lifecycle Safety Infrastructure.
  • Ensure compliance to high quality standards and work with LSM constructively in a matrix framework to achieve project and customer deliverables.
  • Executes administrative operational tasks as required e.g. committee and laboratory management.
  • Collaborate with SO and LSM to help achieve operational departmental goals i.e. understands metrics appropriate to quality document management and assist in the achievement of productivity utilization and realization metrics.
  • Read and acknowledge all necessary standard operating procedures (SOPs) and customer SOPs as required.
  • Ensure all required training is executed in a timely fashion and documented.
  • Work towards ensuring your individual training plan and training transcript are reconcilable.
  • Perform other duties as assigned. 

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES: 

  • Working knowledge of Lifecycle Safety services.
  • Familiarity with functionality of the Regulatory Database and Endpoint Tracking Database.
  • Basic knowledge of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
  • Ability to meet strict deadlines; manage competing priorities and changing demands. Sound organization and time management skills.
  • Ability to follow instructions/guidelines, work independently and on own initiative.
  • Good attention to detail and accuracy and maintain high quality standards.
  • Demonstrate good IT skills.
  • Effective written and verbal communication skills.
  • Ability to be flexible and receptive to changing process demands.
  • Willingness and aptitude to learn new skills across Lifecycle Safety service lines.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients. 

MINIMUM REQUIRED EDUCATION AND EXPERIENCE: 

  • High School Diploma with 5 years relevant experience or Bachelors Degree in scientific or healthcare discipline or equivalent combination of education, training and experience. 

To apply please send resume to: Vickie Dagit, vdagit@apexlifesciences.com 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




917688