Clinical Research Associate Ii - Navi Mumbai, India - Labcorp

Labcorp

Verified Company

Navi Mumbai, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

Essential Job Duties:

The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.
Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of prestudy 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 Labcorp 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 Labcorp 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
Responsible for all aspects of registry management as prescribed in the project plans
Undertake feasibility work when requested
Participate in and follow up on Quality Control Visits (QC) when requested
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of studyrelated documentation, organization of meetings and other tasks as instructed by supervisor
Might be requested to work in a client facing environment
Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
Independently perform CRF review; query generation and resolution against established data review guidelines on Labcorp or client data management systems as assigned by management
Assist with training, of new employees, e.g. comonitoring
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

Experiences:

Minimum Required:

A minimum of 2 (Two) years 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 mínimal 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.

Education/Qualifications/Certifications and Licenses

Recommended:

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.
Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
Thorough knowledge of monitoring procedures
Basic understanding of the clinical trial process

Competencies:

Information purposes only:

Focus on Customer Level 2 (Supports)
Innovate and Change Level 1 (Understands and Considers)
Pursue Scientific and Process Excellence Level 1 (Understands and Considers)
Work with Others Level 2 (Supports)
Achieve Results Level 2 (Supports)
Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors
Demonstrated ability to conduct clinical operations activities effectively and efficiently. ̈ Good attention to detail
Methodical approach to work
Good understanding of medical and clinical research terminology and clinical research processes
An understanding