Sr. Clinical Operations Associate

Confidential Company  •  Madison, NJ

Less than 5 years experience  •  Pharmaceuticals & Biotech

Salary depends on experience
Posted on 07/05/18 by Chitrank Rastogi
Confidential Company
Madison, NJ
Less than 5 years experience
Pharmaceuticals & Biotech
Salary depends on experience
Posted on 07/05/18 Chitrank Rastogi
  • 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 sSOPs.
  • 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 trialmaster 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 experiencepreferred
  • At least 1 year of study management experience
  • Must be familiar with the process and review of budgets
  • 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)
  • Ability to travel up to 5 % of time

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