Covance Senior Clinical Research Associate in Melbourne Australia, Australia

Job Description:

Are you a Clinical Research Associate professional with extensive site monitoring and study site management experience in Australia? If yes, we are expanding our Dedicated CoSource Team and would like to speak with you!

Covance is committed to providing a clinical research career with purpose in a culture that values achievement. By joining our Clinical Operations team, you will work in a collaborative environment with the flexibility to pursue different clinical trials involving various compounds – giving you an excellent overview of best practices across the industry. Clinical Research Associates manage all aspects of study site monitoring according to Covance SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

Whether you’re ready to make a move or just interested in learning more, apply today and let’s talk!

  • 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

About Covance:

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.

Why Covance?

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.

We Offer

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!

Requisition ID: 68611BR

Job Category: Clinical Research Associate

Locations: Australia - Melbourne, Australia - Sydney

Shift: 1

Job Postings: Are you a Clinical Research Associate professional with extensive site monitoring and study site management experience in Australia? If yes, we are expanding our Dedicated CoSource Team and would like to speak with you!

Covance is committed to providing a clinical research career with purpose in a culture that values achievement. By joining our Clinical Operations team, you will work in a collaborative environment with the flexibility to pursue different clinical trials involving various compounds – giving you an excellent overview of best practices across the industry. Clinical Research Associates manage all aspects of study site monitoring according to Covance SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

Whether you’re ready to make a move or just interested in learning more, apply today and let’s talk!

  • 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

About Covance:

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.

Why Covance?

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.

We Offer

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!

Education/Qualifications: Required:

• 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

Preferred:

• Thorough knowledge of Covance SOPs regarding site monitoring

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

Preferred:

• 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

EEO Statement:

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.