Clinical Operations Specialist

Adecco Medical & Science is looking for a Clinical Operations Specialist located in Bridgewater, NJ.

Key responsibilities:

• 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 Company’s SOPs.
• Assist in development of case report forms in collaboration with clinical team
• Support site and vendor selection activities.
• 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.
• Work closely with Bioanalytical Sciences department for pharmacokinetic/pharmacodynamic sample collection and processing activities for all clinical study phases (phase 1 through post-marketing)
• Track and manage study budgets and accruals efficiently and provide timely resolution to financial inquiries.

Education and Experience:

• 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.
• Knowledge of the drug development process.
• Knowledge of GCP/ICH guidelines and FDA regulations.
• Knowledge of EDC system.
• Has received CRA Training from a national clinical research association (eg, ACRP, Barnett International, PERI) (preferred).

To be considered for this Clinical Operations Specialist position or other opportunities available through Adecco Medical and Science, please use the "apply now" button to submit your resume or email directly to majeda.hossain@adeccona.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

  • Apply with Adecco

Reference number US_EN_2_106405_331373