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Senior CRA - Phase 1 Oncology in Bernards, NJ at Apex Life Sciences

Date Posted: 12/12/2018

Job Snapshot

Job Description


Apex Life Sciences is in search of multiple Senior Clinical Research Associates for a global pharmaceutical client! 

Prerequisites:

  • Scientific degree preferred.
  • Minimum – at least 5 years of experience as a Field-based Clinical Research Associate.
  • Experience in Phase I hematology / oncology required.
  • Ability to Travel up to 65% (mostly within US, some international (Canada) possible). Must be located near a major airport to avoid connections/increased travel costs.

Responsibilities include, but are not limited to:

Investigative Site Monitoring - Demonstrate a commitment to quality in all aspects of monitoring; adhere to study monitoring plans; support site identification by conducting feasibility studies as needed; conduct Pre-study Visits for Investigative Sites; conduct Study Initiation Visits at Investigative Sites; conduct Interim Monitoring Visits at Investigative Sites; review the investigator study file and reconcile versus the Trial Master File in compliance with GCP/ICH; perform investigational product accountability and verify storage conditions; coordinate/organize the delivery of supplies as required; and conduct Close-out Visits at Investigative Sites.

Data Integrity - Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of the subjects during their participation in a study; evaluate data query trends and interact with study team in order to improve data quality; assist investigative sites to achieve timely and accurate data entry and resolution of queries; ensure timely submission and review of CRF data and query resolution according to timelines set forth in the SMP; ensure issues of data quality are escalated and resolved/followed-up with the study team and CQA, as needed.

Subject Safety - Monitor the informed consent process; perform safety reviews/SAE reconciliations; verify correct dispensing of IP to subjects; manage Investigative Sites’ adherence to GCP, ICH guidelines and local regulations, ensure prompt reporting of unreported safety events noted during source document review.

Train and Assist Investigative Sites - Train investigative site personnel in GCP/ICH and study-specific requirements, ensure new staff are promptly and adequately trained prior to performing study related activities, and monitor that sites are conducting  clinical research according to the protocol, local regulatory requirements, and other appropriate regulations; serve as liaison between company and assigned sites; build effective and positive relationships with site staff at assigned sites.

Communication - Identify site issues, ensure proper escalation, if necessary, and ensure resolution/follow - up; create monitoring reports, confirmation/follow-up correspondence and telephone contacts for assigned sites; respond to audit findings if applicable; adhere to proper lines of communication; attend and participate in study team meetings as assigned; keep information in the CTMS current; maintain calendar.

Regulatory Documentation - Ensure local requirements are adhered to for IRB updates (annual reports, protocol amendments and study completion/termination and safety reports where applicable); maintain local document files at a country level, as needed; liaise with Regulatory Affairs department for submission and any relevant change to be reported to a Competent Authority.

Skills/Knowledge Required:

  • Significant medical and scientific knowledge
  • Knowledge of investigational products under study
  • Ability to comprehend protocols and supportive information
  • Knowledge of Clinical Development Process
  • Knowledge of regulatory environment and guidelines (ICH, GCP, CFR, EU CT directive and local laws) – knowledge of the local health system
  • Excellent written and oral communication skills including presentations
  • Ability to build excellent working relationship – internally and externally
  • Ability to work in a cross-functional team environment
  • Ability to work independently
  • Working knowledge of SOPs/WPs and policies relevant to position
  • Evidence of problem-solving skills 
  • Ability to resolve routine issues effectively and independently
  • Organizational, prioritization and time management skills
  • Knowledge of software (EDC, CTMS, MS Office, etc.)
  • Ability to travel extensively including overnight stays
  • Appropriate local language skills
  • Fluent written and spoken English
  • Ability to drive a car and have a valid driver’s license

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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.




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