Job Description

Updated: Yesterday
Location: Malaysia-Asia Pacific - MYS-Client-Based, Malaysia
Job ID: 23006597

Description

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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

JOB SUMMARY

The Clinical Research Associate II (CRA II) will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. Performs all tasks routinely and independently, seeking guidance as needed.

JOB RESPONSIBILITIES

\xc2\xb7 Performs site qualification, site initiation, interim monitoring, site management activities 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.

\xc2\xb7 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.

\xc2\xb7 Per the Clinical Monitoring/Site Management Plan (CMP/SMP):

o Assesses site processes

o Conducts Source Document Review of appropriate site source documents and medical records

o Verifies required clinical data entered in the case report form (CRF) is accurate and complete

o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines

o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture

o Verifies site compliance with electronic data capture requirements

\xc2\xb7 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.

\xc2\xb7 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.

\xc2\xb7 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.

\xc2\xb7 For assigned activities, understands project scope, budgets, and timelines; 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.

\xc2\xb7 May act as primary liaison with study 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.

\xc2\xb7 Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.

\xc2\xb7 Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

\xc2\xb7 Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.

\xc2\xb7 For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:

o Site support throughout the study lifecycle from site identification through close-out

o Knowledge of local requirements for real world late phase study designs

o Chart abstraction activities and data collection

o Collaboration with Sponsor affiliates, medical science liaisons and local country staff

o The SMA II may be requested to train junior staff

o Identify and communicate out of scope activities to Lead CRA/Project Manager

o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations

Qualifications

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 .

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 . 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.

Requirements:

\xc2\xb7 Bachelor\'s degree or RN in a related field or equivalent combination of education, training and experience

\xc2\xb7 2 years of clinical monitoring experience

\xc2\xb7 Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

\xc2\xb7 Must demonstrate good computer skills and be able to embrace new technologies

\xc2\xb7 Excellent communication, presentation and interpersonal skills

\xc2\xb7 Ability to manage required travel of up to 75% on a regular basis

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