Clinical Research Associate, Oncology

** Must have 2 years of onsite monitoring experience**

** Must have Oncology experience**

**local/regional travel**

• 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
• 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.

• We are currently seeking a Clinical Research Associate in the Northeast region with Late Phase Onc/Hem experience to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

• What you will be doing
• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.
• Performing data review and resolution of queries to maintain high-quality clinical data.
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports
• Your profile
• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 1.5-2 years of experience as a Clinical Research Associate and Oncology/Hematology experience
• Must be located in NY, NJ, PA, NH, CT, RI, ME or MA.
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Strong organizational and communication skills, with attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license