3 Icon Plc jobs in Thailand

About the role:

The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.

Minimum Qualifications & Experience:

• Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate.
• Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows.
• At least 3-5 years of Clinical Research Associate experience in the Clinical industry.

Responsibilities:

• CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials.
• Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
• In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
• In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
• Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
• Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP.

-Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs.

-Ensure safety issues are reported to the sponsor promptly. ü Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring Plan.

-Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Clinical Monitoring Plan and the Protocol.
- In collaboration with IHCRA or DMA team, ensure the project Trial Master File (TMF) is up to date, current and complete always throughout duration of the study.
- Support sites to be always audit and inspection ready. · Ensure all clinical trial management systems are always current and up to date with all relevant trial data. · Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs. Escalate all key issues as per Issue Escalation SOP. · Collaborate with IHCRA and Site Contract Associates, as applicable, on-site payments, taking ultimate responsibility on site payments to ensure payment execution as per term stated in Clinical Trial Agreement.
- Assist the PM with the development of study related project plans and templates as per study requirements and support tasks as needed for successful study execution. · Demonstrate a thorough understanding of ICH GCP, The Declaration of Helsinki, and any local guidelines as they apply to the investigator, sponsor, monitor, and IEC. · Be aware of and adhere to company processes in areas relevant to a CRA. Be quality focused on the performance of duties. Assist in the review and development of clinical SOPs and processes.
- Participate in activities of the Clinical Services Department, including presentations at clinical department meetings, and assisting with the development of clinical processes and SOPs.
- In collaboration with Business Development (BD), foster relationships with sites to provide feasibility information, as requested, and in accordance with documented feasibility processes. Highlight any BD opportunities to the group
- Understand the responsibilities of Novotech as a service provider in the pharmaceutical and biotech industry and ensure all communications with external and internal customers present a positive professional image of the company.
Senior CRA (SCRA) · Provide mentorship to junior staff and can also provide support to the line manager or project manager in the role of Lead Clinical Research Associate. · Provide the support on ad hoc visits and can be assigned to evaluate and assess junior CRA staff as needed. · Participate in activities of the Clinical Services department, including presenting at clinical department meetings, assisting with the development of clinical processes and SOPs. Identify areas of inefficiency in processes and make recommendations for improvements.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

We are currently seeking a full-time, experienced Clinical Research Associate to join our Clinical Monitoring team in the Thailand. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company's success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you.

Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team.

Through our PACE

Training Program, you will join other Professionals Achieving CRA Excellence and receive customized, expedited training, and efficient onboarding to familiarize experienced CRAs with Medpace systems.

Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
• Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Investigational product/drug accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assessing the clinical research site's patient recruitment and retention success and offering suggestions for improvement;
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Qualifications

• Bachelor's degree with at least 2-4 years of Experience as a Clinical Research Associate;
• Must have a minimum of a bachelor's degree in a health or science related field;
• Proficient knowledge of Microsoft Office;
• Outstanding communication skills; and
• Must be detail-oriented and efficient in time management
• Demonstrated ability to independently function as a Lead CRA (on more complex studies as applicable), including the ability to effectively plan, delegate, and review the work of others;
• Demonstrated ability to present at meetings, including the ability to seek, make, and develop suggestions; and
• Knowledgeable enough about Clinical Monitoring practices and procedures to represent the function in internal and external (e.g., business development) meetings.

Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Awards

• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What To Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.