Senior Clinical Research Associate

サイネオス・ヘルス • Full Time • Quarry Bay, Hong Kong, HK • 4d ago

Updated: Today
Location: Quarry Bay, HK, Hong Kong
Job ID: 25109885

Not ready to apply?
Join our Talent Network

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close out
Knowledge of local requirements for real world late phase study designs
Chart abstraction activities and data collection
As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff
Identify and communicate out of scope activities to Lead CRA/Project Manager
Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
Identify operational efficiencies and process improvements
Develop country level informed consent forms
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
Participate in bid defense meetings

Qualifications:

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected.
Ability to manage required travel of up to 75% on a regular basis

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Roles within Clinical Monitoring/CRA job family are responsible for monitoring during clinical research studies to ensure that the trials are being conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.

Similar Jobs

Application Specialist and Service Engineer

Metrohm China Limited • Full Time • Quarry Bay, Hong Kong, HK • 4w ago

Science / Laboratory / Research & Development Full Time

Job Duties Develop and maintain good customer relationships Responsible for marketing promotions and customer training Identify business opportunities Provide product and application support to customers and dealers Assi...

4w ago

Apply

TTPS ( 高端人才通行證計劃) / QMAS (優秀人才入境計劃) Wealth Management Manager (Monthly Income from HK$30k - HK$80k)

HK Apex Financial Planning Company • Full Time • Quarry Bay, Hong Kong, HK • HK$ 30,000 - HK$ 80,000 / month • 2d ago

Banking / Finance Investment Full Time Wealth Management

Job Descriptions: 1. Market and Develop Professional Financial Services Provision to Clients Wealth Management & Portfolio Advices Global Asset Allocation Investment Planning Retirement Planning Risk Management Plann...

2d ago

Apply

維修技工 (鰂魚涌商廈)

Kerry Properties Limited • Full Time • Quarry Bay, Hong Kong, HK • HK$ 20,000 - HK$ 22,000 / month • 2d ago

Engineering Full Time

職位 : 維修技工 (鰂魚涌商廈) 地區 : 鰂魚涌嘉里中心職責 : 負責處理商廈水電/消防系統及一般冷氣設備之維修保養工作 (有醫療福利及其他津貼/福利) 資歷 : 中三程度; 3年經驗; 良好粵語; 一般普通話優先; 一般英語優先; 懂讀寫中文;...

2d ago

Apply

Supervisor, Technical Services 工程主管 - 鰂魚涌商廈 (A牌)

Kerry Properties Limited • Full Time • Quarry Bay, Hong Kong, HK • 2d ago

Property Full Time

酌情性花紅家屬醫療保險 14天有薪年假、2天家庭關愛假工作地點: 鰂魚涌嘉里中心 (鄰近地鐵站) 工作時間: 5.5天 9小時工作 07:30 to 16:30/ 09:00 to 18:00/ 14:30 to 23:30 (輪休) 職責: 帶領技術員團隊及或獨立處理日常各設施及系統的...

2d ago

Apply

Company Secretarial Assistant

Kerry Properties Limited • Full Time • Quarry Bay, Hong Kong, HK • 3d ago

Professional Services Full Time

Top-tier property developer Promising career path Competitive compensation package Responsibilities: Assist in performing general company secretarial and administrative duties. Maintain corporate records, filing document...

3d ago

Apply

Paralegal - Mixed Corporate Practice

Michael Page • Full Time • Quarry Bay, Hong Kong, HK • 3d ago

Professional Services Compliance Full Time Business Administration

We are looking for a Corporate Paralegal to join an international law firm. This role will allow the candidate the chance to work on different corporate transactions, not just limited to IPO. Client Details Our client is...

3d ago

Apply

Deputy Manager, Technical Services (Commercial Building)

Kerry Properties Limited • Full Time • Quarry Bay, Hong Kong, HK • 3d ago

Building / Construction Full Time

Top-tier Properties Management Company Promising Career Path Competitive Compensation Package Responsibilities: Drive sustainability initiatives and maintain certifications such as ISO, WELL, LEED, IAQ etc, ensuring comm...

3d ago

Apply

Financial Analyst

Kerry Properties Limited • Full Time • Quarry Bay, Hong Kong, HK • 3d ago

Accounting / Audit Full Time

Company description: At Kerry Properties, we commit to employing people who are passionate and dedicated. We look for people who always strive for excellence and possess a positive attitude. In turn, we offer our people...

3d ago

Apply

IT Trainer and Technical Support

Michael Page • Full Time • Quarry Bay, Hong Kong, HK • HK$ 540,000 - HK$ 660,000 / year • 3d ago

Information Technology Full Time

Regional role in legal industry Competitive annual salary with good benefits About Our Client This opportunity is with a mid-sized professional services organization that values innovation and excellence. The company is...

3d ago

Apply

Senior Manager, IT Applications (AI)

SWIRE PROPERTIES LIMITED • Full Time • Quarry Bay, Hong Kong, HK • 3d ago

Information Technology Full Time

Identify key responsibilities and day-to-day duties. Own the AI applications portfolio, ensuring alignment Own AI products and solutions as ongoing capabilities, not just one-off projects ABOUT THE TEAM We are Makers. Ma...

3d ago

Apply