Clinical Research Associate 2

Dexcom; George Town; On-site; MYR 30,000 - 60,000; Full time

Job summary

An established industry player is seeking a dedicated Study Coordinator to join their innovative team. In this pivotal role, you will manage clinical trials, ensuring the safety of participants and the integrity of data collected. Your responsibilities will include coordinating trial subjects, managing day-to-day operations, and working closely with the Principal Investigator. This position offers an exciting opportunity to contribute to groundbreaking research in health technology and make a significant impact on patient care. If you're passionate about clinical research and thrive in a fast-paced environment, this role is perfect for you.

Qualifications

• 2-5 years experience in clinical research is required.
• GCP Certification is mandatory for this role.
• Strong organizational and communication skills are essential.

Responsibilities

• Coordinate and manage clinical trials ensuring compliance with protocols.
• Recruit and manage trial subjects while ensuring their safety.
• Assist with data collection and maintain essential study documents.

Skills

Clinical Research

Good Clinical Practice (GCP)

MS Office Suite

Communication Skills

Organizational Skills

Critical Thinking

Education

Degree in Nursing

Degree in Sciences

Degree in Pharmacy

MBBS/MD

Tools

Clinical Trial Management Systems (e.g. Veeva)

Job description

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Position Summary

Join our dynamic and growing global team as a Study Coordinator (SC), where you'll play a pivotal role in the conduct of clinical trials. You'll be responsible for a variety of activities, essential to the success of these trials, including trial start-up activities, ongoing study management, and coordination of trial subjects at every stage of their clinical trial journey. As the main point of contact for trial subjects, you'll work closely with the Principal Investigator (PI) to ensure the safety of patients and the integrity of data collected, in accordance with study protocol requirements, Good Clinical Practice (GCP), and applicable regulatory requirements.

Essential Duties And Responsibilities

• Clinical Function:
• 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.
• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Dexcom’s SOPs.
• 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.
• Trial Planning and Coordination:
• 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.).
• Data Collection and Management:
• Ensure timely and accurate completion of Case Report Forms (CRF/e-CRF) and resolve queries.
• Maintain essential study documents/files and make records available for review, including but not limited to, device accountability tracking.
• Keep an ongoing record and assessment of adverse events (AEs), and serious adverse events (SAEs).
• Assist with departmental audits of clinical studies and procedures.
• Compliance and Ethics:
• Ensure trial practices reflect ethical and legal standards for clinical trials.
• Adhere to all Dexcom SOPs, ISO 14155:2020, and Malaysian Guideline for Good Clinical Practice
• Notify the Ethics Committee of SAEs and protocol deviations (PDs).
• Prepare the site for monitoring, audit, and inspection, and implement recommended corrective actions.
• Administrative Support:
• Observe the progress of trial activities and communicate schedules/required procedures to the team.
• Assist with dispensing participants’ compensation (if applicable)
• Coordinate trial close-out activities, including device investigation or disposal and archiving materials.
• Involve in and contribute to all quality improvement activities of the department.
• Collaborate with global Clinical PMO and study teams to establish and maintain study timelines.
• Communicate effectively and professionally with coworkers, leadership, and study subjects.
• 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.
  

Required Qualifications

• 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
  
  

Preferred Qualifications

• 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
  
  

Travel Required

• None
  
  

Language Skills: Must be able to communicate effectively in English. 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.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be required to perform the following Physical Activity: Standing, walking, sitting, using hands, handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear, taste or smell. May be required to lift 0 lbs. 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.

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.