FSP - Sr. Clinical Research Associate - Oncology FSP (Alberta Home Based)
Covance
Calgary, AB
Job Overview
Discover new opportunities to grow your career as a Covance FSP CRA

Are you ready to redefine what’s possible, and discover your extraordinary potential at Covance? A career here provides the unique chance to create a lasting impact and difference in our patient’s lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy & collaborative work place, along with access to comprehensive benefits. Your work will be meaningful, the patient outcomes are real, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

Our mission is to help our clients bring the miracles of medicine to market sooner - join us for your next career move.

Essential Job Duties:
Working within an FSP model, embedded within a client
Oncology Monitoring experience
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
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
Travel, including air travel, may be required and is an essential function of the job.
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 and trip report review as assigned
Review progress of projects and initiate appropriate actions to achieve target objectives
Organize and make presentations at Investigator Meetings
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
Conduct, report and follow-up on Monitor Quality Control Visits (MQC) or Quality Control Visits (CQC) 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
Coordinate 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

Education/Qualifications

Minimum Required:
External Candidates

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure),

AND

a minimum of 4 years of Clinical Monitoring experience.

In lieu of the above education requirement, external candidates with a minimum of 6 years recent clinical monitoring experience will be considered.

Internal Candidates

Internal candidates with a minimum of 4 years of clinical monitoring experience.
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
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.

Experience

Minimum Required:
External Candidates
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure),

AND

a minimum of 4 years of Clinical Monitoring experience.

In lieu of the above education requirement, external candidates with a minimum of 6 years recent clinical monitoring experience will be considered.

Internal Candidates
Internal candidates with a minimum of 4 years of clinical monitoring experience.
Oncology Monitoring experience
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
Valid Driver’s License

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