Sr Clin Res Assoc
hace 30 días

Job Overview

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

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

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

Required :

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

Job Number 2018-19993

Job Category Clinical Research Associate

Position Type Full-Time

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

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