Clinical Operations Specialist - Clinical Pharmacology - NJ in Madison, NJ at Apex Life Sciences

Date Posted: 10/2/2018

Job Snapshot

  • Employee Type:
  • Location:
    Madison, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Job Description:

  • Serve as operational study lead for assigned Clinical Pharmacology studies, participating in activities during pre-study, start up, conduct phase and close out 
  • Ensure timely execution of studies in accordance with GCP and SOPs. 
  • Assist in development of case report forms in collaboration with clinical team 
  • Support site and vendor selection activities 
  • Review study monitoring plans 
  • Participate in reviewing and testing of specifications and edit checks for the electronic data capture (EDC) system 
  • Review eCRF completion guidelines and lab requirements 
  • Work with Data Management and Clinical Standards to ensure data collection meets standard 
  • Develop and deliver study specific training presentations at study start and provide ongoing training to the sites during study conduct, as needed 
  • Review/author informed consent forms and support their submission to IRBs 
  • Author/review study procedure manuals, pharmacy manuals and/or laboratory manuals 
  • Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies 
  • Conduct study team meetings as appropriate; support the timely execution of milestones and discuss important study related information 
  • Work closely with Bioanalytical Sciences department for pharmacokinetic/pharmacodynamic sample collection and processing activities for all clinical study phases (phase 1 through post-marketing) 
  • Document and track protocol deviations and violations 
  • Report high-level issues to Clinical Pharmacologist and Safety Physician with an organized approach Provide viable options for resolution based on prior experience and current study trends 
  • Respond to site and vendor issues 
  • Generate and resolve data queries in EDC. Participate in SAE reconciliation with clinical team 
  • Review and respond to Sponsor site audit findings 
  • Work with Contracts Management/Procurement to review and execute site and vendor contracts 
  • Coordinate successful transmission of all study data 
  • Perform clinical data review of data listings and summary tables; review queries 
  • Ensure completion of trial master files 
  • Review drug packaging and labeling and oversee the shipment of drug supply to ensure delays do not occur 
  • Track and manage study budgets and accruals efficiently and provide timely resolution to financial inquiries 
  • Participate in the preparation of clinical trial synopses/outlines and protocols. 
  • Participate in process improvement activities 
  • Create/revise SOPs related to clinical study operation activities 
  • Provide support during CSR development, such as review of TFLs and CSR and availability of certain CSR components 
  • May perform study monitoring, create/review study monitoring plans, and prepare monitoring visit reports, confirmation letters, and follow up letters 

Minimum Requirements: 

  • B.S. or M.S. degree in life sciences or equivalent 
  • 3+ years of clinical research experience, Phase I experience required 
  • At least 1 year of study management experience 
  • Must be familiar with the process and review of budgets, forecasting and accruals 
  • Experience in developing study outlines and reviewing protocols; 
  • Experience in data clarification and/or query resolution; 
  • Multi-tasking and capability to take on additional responsibilities are required 
  • Knowledge of the drug development process 
  • Knowledge of GCP/ICH guidelines and FDA regulations 
  • Knowledge of EDC system 
  • Basic medical and scientific knowledge. 
  • Good organizational and interpersonal skills 
  • Ability to work independently 
  • Ability to communicate effectively verbally and in writing. Good presentation skills 
  • Experience using organizational and tracking tools 
  • Efficient in computer and software skills (Word, Excel, Powerpoint) 
  • Has received CRA Training from a national clinical research association (eg, ACRP, Barnett International, PERI) (preferred)


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.