Lowongan Kerja Sr CRA I Hybrid Sponsor Office And Home Based Syneos - Clinical and Corporate - Prod Jakarta 2024
Syneos - Clinical and Corporate - Prod JakartaLowongan Kerja Syneos - Clinical and Corporate - Prod 2024 - Syneos - Clinical and Corporate - Prod saat ini membuka kesempatan berkarir untuk Kalian melalui Lowongan Kerja Terbaru guna mengisi posisi jabatan sebagai Sr CRA I Hybrid sponsor office and home based yang akan ditempatkan di Jakarta. Silakan lihat keterangan rekrutmen selengkapnya berikut ini :
Loker Syneos - Clinical and Corporate - Prod 2024
Deskripsi Lowongan Kerja Sr CRA I Hybrid sponsor office and home based Jakarta Terbaru
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 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 EVERYWHEREWhy 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.
- 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
What we're looking for
- 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.
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.
Pendaftaran :
Jika Anda berminat dan memenuhi persyaratan diatas, silakan melakukan pendaftaran secara online melalui tautan berikut ini :
Keterangan Lain :
- Hanya pelamar terbaik lah yang akan diundang untuk mengikuti tahap rekrutmen selanjutnya.
- Lowongan Syneos - Clinical and Corporate - Prod ini tidak dipungut biaya apa pun.
Apabila Saudara belum tertarik dengan Loker Sr CRA I Hybrid sponsor office and home based Jakarta September 2024 Syneos - Clinical and Corporate - Prod di atas, maka Anda dapat mencoba melihat info pekerjaan yang serupa dari beberapa perusahaan di Jakarta di bawah ini.
Related Jobs:
Lowongan Kerja Teknisi Listrik
Melakukan pemasangan unit sesuai dengan kondisi kontrak baik total unit, spesifikasi dan limit material/service Melakukan service berkala sesuai jadwal service dan material yang sesuai kondisi
Lowongan Kerja Internal Audit Staff
WORK AT IMPACK Impack is a company deeply committed to progress and dynamic growth. Our workplace fosters an environment where your potential takes center stage.
Lowongan Kerja Staff IT Operation & Infrastructure
Staff IT Operation & Infrastructure Kode Lowongan : [( ITO )] Status : Full Time Tanggal Posting : 29 March 2022 Deskripsi Pekerjaan : Memelihara
Lowongan Kerja Remote Psychiatrist
Company Overview: MantraCare is pioneering accessible mental health care through a user-friendly mobile application. Our platform connects clients with experienced psychiatrists worldwide using video consultations,
Lowongan Kerja INTERNAL AUDIT & RISK MANAGEMENT INTERN
Description : As an Internal Audit Intern, you will assist in administrative tasks related to risk assessments, support the audit team in managing and accelerating