Lowongan Kerja Clinical Research Associate di MSD

Deskripsi Pekerjaan :

Info Terbaru Seputar Pekerjaan dari Perusahaan MSD sebagai posisi Clinical Research Associate. Jika Lowongan Kerja Clinical Research Associate di Jakarta ini sesuai dengan kriteria anda silahkan langsung mengirimkan lamaran / CV Terbaru anda melalui situs loker terkini dan terupdate Lokerindo.ID

Setiap pekerjaan mungkn tidak lah mudah untuk di lamar, karena sebagai kandidat baru / calon pegawai harus memenuhi beberapa kualifikasi dan persyaratan sesuai dengan kriteria yang dicari dari Perusahaan tersebut. Semoga info karir dari MSD sebagai posisi Clinical Research Associate dibawah ini sesuai dengan Kualifikasi anda.

JOB DESCRIPTION

Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcarepany, one that is ready to help create a healthier future for all of us.

Clinical Research Associate is accountable for performance andpliance for assigned protocols and sites in a country. Under the oversight of the CRA manager, the person ensurespliance of study conduct with ICH/GCP and country regulations, Our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. This person acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. CRA also actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

ROLES & RESPONSIBILITIES

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities inpliance 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 related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & proes inputs on site selection and vaation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure: (1) Data generated at site areplete, accurate and unbiased, (2) Subjects’ right, safety and well-being are protected.
• Conducts site visits including but not limited to vaation visits, initiation visits, monitoring visits, close-out visits and records clear,prehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality orpliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
• Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Performs co-monitoring visits where appropriate.
• Following the country strategy defined by CRD and/or CRA manager, contributes to theentification of new potential sites and works closely with them to develop strong clinical research capabilities.

REQUIREMENTS

• Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
• B.A./B.S. with strong emphasis in science and/or biology

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at ourpany without a va written search agreement in place for this position will be deemed the sole property of ourpany. No fee will be p in the event a canate is hired by ourpany as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Va Driving License:

Hazardous Material(s):

Requisition ID:R255645

Info Pekerjaan :

• Perusahaan : MSD
• Posisi : Clinical Research Associate
• Lokasi Kerja : Jakarta
• Negara : ID

Cara Mengirimkan Lamaran :

Setelah Membaca dan telah mengetahui kriteria dan kebutuhan minimum kualifikasi yang telah dijelaskan dari info pekerjaan Clinical Research Associate di kantor Jakarta diatas dengan demikian jobseeker yang merasa belum memenuhi persyaratan meliputi pendidikan, umur, dll dan memang merasa berminat dengan lowongan kerja terbaru Clinical Research Associate, pada bulan ini 2023 diatas, hendaknya secepatnya untuk melengkapi dan menyusun berkas lamaran kerja seperti surat lamaran kerja, CV atau daftar riwayat hidup, FC ijazah dan transkrip dan pelengkap lainnya seperti yang telah dijelaskan diatas, guna mendaftar dan mengikuti seleksi masuk penerimaan pegawai baru diperusahaan yang dimaksud, dikirim melalui link Halaman Selanjutnya di bawah ini.