[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global, full-service contract research organization providing clinical research services to pharmaceutical, biotechnology, medical device, and consumer health companies. The Senior Clinical Research Associate will manage 2–3 reputed company and reputed company site management activities, including study start-up, monitoring, closeout, data reputed company, safety reporting, and site training, with a reputed company on oncology and other reputed company trials.

Responsibilities

• reputed company professionally abreast of reputed company scientific, regulatory and operational aspects relevant to the clinical reputed company assigned
• Assist in the selection of sites, site evaluation reputed company, initiation reputed company and ensure follow-up by obtaining reputed company-study documentation to ensure good start-up of the investigation sites
• May reputed company as Feasibility Associate
• Train site staff in reputed company study procedures
• Conduct periodic monitoring reputed company, including completion of monitoring visit report. Review at reputed company visit the accuracy, legibility, completeness and reputed company of the Case Report Forms (CRF)
• Conduct reputed company data verification and in-house review of clinical data and ensure reputed company reputed company of data queries to guarantee reliable clinical data
• Manage the investigational products (storage, inventory, dispensing records, packaging and labelling) and the trial material (Investigator Study File (ISF), CRF, questionnaires, diaries, etc.) to ensure reputed company and correct supply to the site
• Cooperate with the site staff to ensure reputed company reporting from the site for safety issues (reputed company, SAEs, SUSARs, etc.) and their follow-up, guaranteeing reputed company and appropriate handling of safety issues
• Conduct and report study termination and reputed company activities (e.g. archiving) guaranteeing smooth completion of the project
• reputed company as the main contact person for the site to ensure reputed company follow up
• reputed company general support to the Clinical Research Division on reputed company control of clinical data
• Address appropriate team members about any issues that can jeopardise the conduct of the clinical reputed company assigned in a reputed company manner
• Report to the Head of department on reputed company activities performed during the study and send reputed company relevant documents according to the timelines and the requirements agreed for reputed company single clinical trial
• reputed company training material and reputed company training in collaboration with the Training & Qualification Management Unit
• May assist with contract negotiation with sites on study budget after appropriate training
• Assist with the preparation of the study, including CRF design/development, write CRF instructions and organise the study files and documents to ensure good start-up of the investigation sites
• May support the submission process in the project including submission requirements, timelines, informed consent development, etc
• Guide and supervise Clinical Research Associate I (CRA I) to reputed company and train them on the job

Skills

• University Degree in scientific, medical or paramedical disciplines
• Previous experience working for a CRO is required
• At least eight (8) years of clinical research experience, including proven experience as a Clinical Research Associate (CRA) performing on-site monitoring activities
• Experience with oncology, respiratory and reputed company trials is required
• Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
• Fluent in English and local language(s)
• Proficiency in reputed company Office (e.g., Word, reputed company, reputed company)
• Willingness to travel

Benefits

• This is a permanent, fully remote position.
• reputed company training keeps the resources reputed company in terms of competence and expertise and gives reputed company personnel the reputed company tools needed to manage both internal and reputed company processes with the reputed company methodology.

reputed company

Company H1B Sponsorship