Cra Ii or Sr Cra

3 months ago

กรงเทพมหานคร, Thailand Syneos - Clinical and Corporate - Prod Full time

**Description**

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**

**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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

**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.
- 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
- 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.
- 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 requi

  • Cra Ii

    6 months ago

    กรุงเทพมหานคร, Thailand ICON Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Cra Ii

    6 months ago

    กรุงเทพมหานคร, Thailand ICON plc Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Sr Cra I

    6 months ago

    กรุงเทพมหานคร, Thailand Syneos - Clinical and Corporate - Prod Full time

    **Description** **Senior Clinical Research Associate I** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and...

  • Assistant Cra

    7 months ago

    กรุงเทพมหานคร, Thailand Thermo Fisher Scientific Full time

    **Assistant CRA - Thailand** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking...

  • Assistant Cra

    1 week ago

    กรุงเทพมหานคร, Thailand Thermo Fisher Scientific Full time

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Assistant CRA - Thailand** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our...

  • Assistant Cra

    4 weeks ago

    กรุงเทพมหานคร, Thailand Thermo Fisher Scientific Full time

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Assistant CRA - Thailand** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our...

  • Associate Cra

    6 months ago

    กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol...

  • Associate Cra

    6 months ago

    กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol...

  • Associate Cra

    6 months ago

    กรุงเทพมหานคร, Thailand MSD Full time

    **WHAT YOU WILL DO** **Key Responsibilities**: - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. -...

  • Clinical Research Associate Manager

    6 months ago

    กรุงเทพมหานคร, Thailand MSD Full time

    **Clinical Research Associate Manager** **THE OPPORTUNITY** This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Head of Monitoring Resources or the CRD, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations,...

  • Sr. Cra

    6 months ago

    กรุงเทพมหานคร, Thailand Thermo Fisher Scientific Full time

    Job DescriptionAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide with resources needed to achieve individual career goals while taking science a step beyond...

  • Cra

    7 months ago

    กรุงเทพมหานคร, Thailand Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...

  • Clinical Research Associate Ii

    6 months ago

    กรุงเทพมหานคร, Thailand Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Research Associate

    6 months ago

    กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...

  • Senior Clinical Research Associate

    6 months ago

    กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...

  • Senior Clinical Research Associate

    6 months ago

    กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...

  • Clinical Research Associate

    6 months ago

    กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...

  • Assistant Cra

    8 months ago

    กรุงเทพมหานคร, Thailand Thermo Fisher Full time

    Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned. Completes and documents study-specific training. Orients and trains on any company/study-specific systems. Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project. Supports to...

  • Clinical Research Manager

    3 months ago

    กรุงเทพมหานคร, Thailand MSD Full time

    This position is responsible for project management of the assigned studies, accountable for performance for assigned protocols, leads local study teams to high performance on trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert etc. **WHAT YOU WILL DO** **Key Responsibilities**: - Main Point of Contact...

  • Associate Clinical Research Manager

    6 months ago

    กรุงเทพมหานคร, Thailand MSD Full time

    With support of other CRMs and/or TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, the company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. The aCRM could be...