Icon Hiring Clinical Research Associate - Onsite Monitoring: Unlock Your Career in Clinical Research with ICON
About the ICON plc
ICON plc, a global healthcare intelligence and clinical research organization dedicated to advancing clinical research from molecule to medicine. With a focus on providing outsourced services to pharmaceutical, biotechnology, medical device, and government organizations, ICON is at the forefront of accelerating the development of drugs and devices that save lives and enhance the quality of life. Our commitment to patients, coupled with the passion and expertise of our people, makes ICON a leader in the industry.
Company Vacancies List
Position: Clinical Research Associate (CRA)
- Location: Delhi , Mumbai
- Experience: 01+ years of onsite monitoring experience
- Therapeutic Area: Oncology
If you are an experienced CRA looking for new opportunities or considering a move to Delhi, this is your chance to join our team. We are seeking dedicated professionals to contribute to our mission of advancing clinical research.
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Join ICON as a Clinical Research Associate in Delhi![/caption]
Job Description
As a Clinical Research Associate at ICON, you will play a pivotal role in the successful management of investigator sites throughout the trial lifecycle. Key responsibilities include:
Requirements:
💥Minimum 01 years of onsite monitoring experience required.
💥Can be home-based (priority would be in major cities that will have good connectivity)
💥 During new-hire orientation & training: must come to Delhi Office for 3-4 weeks of training.
💥Therapeutic : Cardiovascular/ Oncology or any other TA experience but should have extensive hands on experience.
About the Department & Responsibilities
Our Clinical Operations team is unparalleled in its dedication to success. As a Clinical Research Associate, you will receive the support needed to develop both personally and professionally. Operating as a key part of a global study team, you will play a fundamental role in our clients' drug development processes.
- Recognize, exemplify and adhere to ICONs values which centre on our commitment to People, Clients and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Ability and willingness to travel at least 60% of the time (international and domestic : fly and drive)
- Expert knowledge of ICON's SOPs/WPs, ICH, GCP and appropriate regulations.
- Familiarity with ICON systems
- Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
- Recruitment of investigators.
- Independent and proactive coordination of all the necessary activities required to set up and monitor a study, including but not limited to the following:
- Identify investigators.
- Help when requested, in preparation of regulatory submissions. Design of patient information sheets and consent forms.
- Ensure timely submission of protocol/consent documents for ethics/IRB approval. Pre study/placement and initiation visits. Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/sponsor site monitoring SOP, as appropriate
- Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets. Complete accurate study status reports.
- Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
- Keep the Project Manager regularly informed.
- Process case record forms to the required quality standards and timelines. Deal with sponsor generated queries in a timely manner.
- Ensure the satisfactory closeout of investigator sites.
- Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
- Participate in feasibility studies for new proposals as required. Ensure correct archiving of files on completion of a study.
- Maintain patient and sponsor confidentiality.
- Assume additional responsibilities as directed by the Project Manager.
- investigational Products (IPs) stored and managed by the site:
- Ensure storage conditions and acceptable supplies are provided
- Ensure IPs are supplied only to eligible patients o Ensure IP receipt, use and return are controlled and documented
- Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.
- Act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project Manager if appropriate
- Participate in data listing reviews, as applicable.
- Responsible for cost effectiveness
- Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
- Assist with marketing the company if and when appropriate.
- Other duties as assigned.
- Key responsibilities:
- Site Monitoring
- SIV ~ COV
- PI Management
- audit & inspection
- NDCT Rule
Experience:
- More than 1.5 years of site monitoring experience
- Location : India
- Education: B.Pharm/M.Pharm/Pharm D/BDS/MBBS
- Experience: minimum 1 year of onsite monitoring (excluding any training & induction) of respiratory/cardiology/nephrology studies
- Good Communication
https://pharmastuff.org.in/job/join-icon-plc-hiring-clinical-research-associate
