Clinical Research Associate 2

Ensure the smooth and efficient day-to-day operation of clinical trials. Schedule and manage subject visits, including unscheduled visits, as per protocol requirements. Recruit, consent, screen, instruct, and coordinate research subjects. Identify and escalate safety events and major protocol deviations. Assist with assessing trends for safety and protocol deviations and communicate findings to the PI. Propose and implement corrective and preventative actions. Provide documents and information for Ethics Committee applications. Perform tasks as delegated by the PI in accordance with the protocol, SOPs, and applicable guidelines. Assist in finding potential subjects through pre-screening activities. Prepare supplies and account for devices required for clinical studies. Set up IT equipment for studies. Develop clinical study materials (including, but not limited to, source documentation, IRB submissions, training slides, etc.). Ensure timely and accurate completion of Case Report Forms (CRF/e-CRF) and resolve queries. Assist with departmental audits of clinical studies and procedures. Ensure trial practices reflect ethical and legal standards for clinical trials. Notify the Ethics Committee of SAEs and protocol deviations (PDs). Prepare the site for monitoring, audit, and inspection, and implement recommended corrective actions. Assist with dispensing participants' compensation (if applicable) Coordinate trial close-out activities, including device investigation or disposal and archiving materials. Collaborate with global Clinical PMO and study teams to establish and maintain study timelines. Collaborate effectively with peers and leadership across departments and professionally interact/build relationships with FDA, IRB, and key opinion leaders. Perform other duties as assigned under minimal supervision. Degree in nursing, sciences, or pharmacy. MBBS/MD with clinical experience will also be considered 2-5 years relevant working experience in clinical research GCP Certification Proficient with MS Office Suite Excellent communication skills and ability to work effectively with multiple global functions Strong organizational skills and ability to manage competing priorities Strong critical thinking and independence Willing to work, hands-on, in an extremely fast paced environment with high attention to details and accuracy Experience in continuous glucose monitoring (CGM) or diabetes-related studies Experience working closely with a global team Experience with Clinical Trial Management Systems (e.g. Veeva) Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships Excellent organizational skills, attention to detail and a Data-driven, decision-making mindset Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. to over 100 lbs. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be exposed to the following environmental conditions: Wet or humid conditions, work near moving parts, work in high - precarious places, fumes or airborne particles, toxic or caustic chemicals, outdoor weather conditions, extreme heat (non-weather), extreme cold (non-weather), risk of electric shock, work with explosives, risk of radiation, vibration. The noise level in this work environment can range from quiet to very loud.