Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Post : Senior Clinical Research Associate
Job Description
• Responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring Responsibilities:
* Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
* Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
* Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data
* Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy
• Prepare accurate and timely trip reports
• Manage small projects under direction of a Project Manager/Director as assigned
• Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned
• Review progress of projects and initiate appropriate actions to achieve target objectives
• Organize and make presentations at Investigator Meetings
• Report, write narratives and follow-up on serious adverse experiences
• Participate in the development of protocols and Case Report Forms as assigned
• Participate in writing clinical trial reports as assigned
• Interact with internal work groups to evaluate needs, resources and timelines
• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
• Responsible for all aspects of registry management as prescribed in the project plans
• Undertake feasibility work when requested
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
• Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
• Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
• Assist with training, mentoring and development of new employees, e.g. co-monitoring
• Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
• Perform other duties as assigned by management
Candidate Profile
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
• In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
• Thorough understanding of the drug development process
• Fluent in local office language and in English, both written and verbal
For more info on next page...
Subscribe to Pharmatutor Job Alerts by Email
Experience
• Minimum of four (4) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
• In lieu of the above requirements, candidates with > four (4) years supervisory experience in a health care setting and three (3) years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may be considered
• Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Excellent site monitoring skills
• Excellent study site management skills
• Excellent registry administration skills
• Ability to work with minimal supervision
• Good planning and organization skills
• Good computer skills with good working knowledge of a range of computer packages
• Excellent verbal and written communication skills
• Ability to train and supervise junior staff
• Ability to resolve project-related problems and prioritizes workload for self and team
• Ability to work within a project team
• Works efficiently and effectively in a matrix environment
Additional Information
Experience : 4 years
Qualification : University/college degree
Location : Gurgaon
Industry Type : Pharma
Functional Area : Clinical Operations
End Date : 5th July, 2018
See All Gurgaon Alerts Delhi Alerts B.Pharm Alerts B.Sc Alerts
See All Other Jobs in our Database
.png)
