Are you a Clinical Research Associate (CRA) professional with extensive site monitoring and study site management experience in India? If yes, we are seeking qualified CRAs for our Dedicated CoSource Team and would like to speak with you!
In this upcoming re-monitoring studies, you will work in a collaborative environment pursuing clinical trials involving various sites in India – giving you an excellent overview of best practices across the industry. Clinical Research Associates manage study site monitoring according to Covance and sponsor's SOP, GCP, and ICH guidelines. This will be a twelve-month contract position.
- All aspects of site management as prescribed in the project plans
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
- Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements
- Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
- Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
- Ideally have been in all stages of clinical research monitoring experience
- Experienced in Cardiovascular or Endocrinology studies area
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Excellent understanding of Serious Adverse Event (SAE) reporting
- Ability to resolve project-related problems and prioritize workload for self and team
Covance is one of the world’s largest and most comprehensive drug development services companies, with more than 11,000 employees in 60 countries. We began operations Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Through our discovery, nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
We welcome your application and believe this decision may be the most rewarding career move you will ever make!
• 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
• Thorough knowledge of Covance SOPs regarding site monitoring
• 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
• Advanced site monitoring skills
• Advanced study site management skills
• Advanced 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
• Advanced 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
• One (1) or more year’s additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
• Local project coordination and/or project management