Covance

Clinical Research Associate

Job Location(s) PH-Manila
Job Number
2021-68128
Job Category
Clinical Research Associates
Position Type
Full-Time
Telecommute
No

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:
o  Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
o  Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
o  Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
o  Monitor data for missing or implausible data
o  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
·        Ensure audit readiness at the site level
·        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 Quality Control (QC) visits 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
·        Track and follow-up on 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

- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.

Experience

- A minimum of 1 (One) year of Clinical Monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted.
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines
- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Good planning, organization and problem-solving abilities
- Ability to work with minimal supervision
- Good communication and interpersonal skills
- Good analytical and negotiation skills
- Computer competency
- Fluent in local office language and in English, both written and verbal
- Works efficiently and effectively in a matrix environment
-  Preferred:
- One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred, however an equivalent combination of education and experience to successfully perform the key responsibilities of the job.

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