Clinical Research and Development Specialist - NJ in Summit, NJ at Apex Life Sciences

Date Posted: 2/2/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Summit, NJ
  • Job Type:
    Research
  • Experience:
    At least 1 year(s)
  • Date Posted:
    2/2/2018
  • Job ID:
    810200

Job Description


Description:

  • Degree in life sciences 
  • Experience working on oncology or hematology clinical trials 
  • Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data.
  • Ability to identify discrepancies in clinical trial data and to write queries from a medical perspective. 
  • Familiarity with INFORM, RAVE, J-review or other clinical databases or other data review tools (patient profiles, listings) would demonstrate the candidate's familiarity with the scope of work. 
  • Some experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, patient narrative 
  • Ability to communicate medical or clinical information to a physician. 
  • Ability to understand clinical trial publications; understanding of disease 
  • Candidate should have direct experience working on clinical trials from a sponsor's perspective. 
  • At least one year in a CR&D capacity performing data review in oncology/hematology. (new proposal to add)
  • This position is different in scope from a CRA position (new proposal to add)

Responsibilities:

  • Support assigned study level activities for 1 or more clinical studies with minimal supervision (may lead or co-lead a study or study activities) 
  • Support/Lead/Co-Lead all study start up/conduct/close-out activities as applicable. 
  • Preparation, storage, maintenance of clinical documents (TMF) 
  • Clinical Development Planning 
  • Protocol Development (writing, reviewing, amending and comment resolution) 
  • Clinical Study Report 
  • Regulatory Documents (e.g., IB, Briefing Books) 
  • Informed Consent Forms 
  • Site and CRA training materials 
  • Country/site selection activities 
  • Collaboration with Clinical Operations for budget preparation, CRO scope of work, etc 
  • Collaborate with study team members (Clinical, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management) to ensure that key milestones are met on time and with high quality 
  • Regularly attend and actively participate in study team and other clinical meetings 

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 employeeservices@apexsystemsinc.com or 844-463-6178.