Clinical Assistant

Records Management & Document Control (Administration & Office Support)
Full time
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•Track, scan, code, input meta data, and/or apply naming convention and send/file documents to the relevant study Trial Master File (TMF) as per the Trial Master File Plan.
• Filling and Archiving paper wet-ink documents in the Central Files office location as per the Trial Master File plan
• Photocopy, print, distribute and retrieval of documents, as needed
• Support on creating and review of Note to Files (NTF)
• Maintain basic quality check procedures to ensure accurate maintenance of documents
• Review/update TMF country and site issues in 30 days
• Review/update EDL (Essential Documents List)
• Review/update TMF milestones
• Clear QC stops (if applicable)
• Missing Letter Support (e.g. FUP letter, confirmation letter, cover e-mails, etc...)
• Follow up with sites regarding pending documents
• Transfer of documents to sponsor TMF systems (if applicable)
Vendor Management
Track and manage vendor communication related to site staff access to systems (e.g. EDC, IVRS) during activation
• Follow up with sites
• Study specific completion training
Payment Support
•Review if Site payments funds are completed as per site contracts and follow up with responsible team accordingly
Support to all local site management team members (CRA, iCRA, COL, SSUL)
Skills:
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
• Maintain a basic knowledge and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations and applicable PAREXEL procedures
• Good oral and written communication skills to internal and external customer
• Flexibility to perform multiple tasks and ability to prioritize these to achieve project timeline
• High commitment to and performs consistently high-quality work
• Effective problem-solving skills
• Mentor and train less experienced staff as appropriate
• Active participant as a process and/or platform Subject Matter Expert (SME) with minimal LM oversight
• Demonstrate attitude, teamwork, proactiveness and confidence
Knowledge and Experience:
• Experience in office management in an international environment would be advisable
Parexel International PAREXEL INTERNATIONAL CO., LTD
From its pioneering beginnings as one of the first clinical research organizations (CROs) more than two decades ago to its place as one of the top three public global service providers today, PAREXEL has evolved to provide a broad range of services to the bio/pharmaceutical industry. Clients have relied on the Company to provide integrated clinical development, regulatory affairs consulting, and commercialization services, as well as to offer technologies that expedite time-to-market.
Founded - PAREXEL was founded in 1982 by Josef von Rickenbach and organic chemist Anne Sayigh to provide regulatory consulting services. The company takes its name from Paracelsus, the Swiss physician, scientist and natural philosopher, who is celebrated as the father of modern empirical chemistry.
On 2007, PAREXEL International Corporation announced the successful completion of the acquisition of Taiwan-based APEX International Clinical Research Co., Ltd. ("APEX". The acquisition strengthens PAREXEL's global capabilities, providing clients with a wide range of clinical research service offerings throughout the Asia-Pacific region, including mainland China, Hong Kong, India, Taiwan, Singapore, Indonesia, South Korea, Malaysia, Thailand, the Philippines, New Zealand, and Australia
Growth - Over the last 25 years, PAREXEL has expanded its portfolio of services and global footprint through a combination of organic growth, alliances, and acquisitions, including the purchase of CROs in emerging geographies, in order to provide expanded capabilities for its clients?clinical development programs.
Innovation - PAREXEL has made several innovative contributions to the advancement of the bio/pharmaceutical industry during its history, and was one of the first companies to formally define the contract service provider sector. PAREXEL broke new ground in the early 1980s by conceiving of a highly complex, multi-disciplinary and systems-oriented approach to outsourced clinical development, bringing efficiencies, speed, scalability and standardization to the process. As the industry adopted new software and Internet-based systems, PAREXEL created an industry-leading advanced technology offering. Today, PAREXEL is a front runner in providing eClinical solutions through its subsidiary Perceptive Informatics, Inc.
Focus - PAREXEL has remained focused on its mission to help clients find new ways to prevent and cure disease, contributing to the development and launch of many new drugs and treatments. PAREXEL's experts, who have experience across a broad range of therapeutic areas, have supported nearly all of the top 50 best-selling drugs that are on the market today.
Vision, Mission and what we value
Our Vision
PAREXEL strives to be the premier provider to the bio/pharmaceutical and medical device industries for development and commercialization of new medical therapies worldwide.
Our Mission
PAREXEL's mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.
What we value
• Integrity & Ethics
• Sense of Urgency
As a leading CRO in the Asia-Pacific region, PAREXEL INTERNATIONAL is committed to create a teamwork environment where each employee can be motivated and nurtured both in the personal and professional levels. We provide our employees with necessary assistances, certifications, resources and technical trainings that are crucial to ensure they perform their duties successfully.
PAREXEL INTERNATIONAL CO., LTD
From its pioneering beginnings as one of the first clinical research organizations (CROs) more than two decades ago to its place as one of the top three public global service providers today, PAREXEL has evolved to provide a broad range of services to the bio/pharmaceutical industry. Clients have relied on the Company to provide integrated clinical development, regulatory affairs consulting, and commercialization services, as well as to offer technologies that expedite time-to-market.
Founded - PAREXEL was founded in 1982 by Josef von Rickenbach and organic chemist Anne Sayigh to provide regulatory consulting services. The company takes its name from Paracelsus, the Swiss physician, scientist and natural philosopher, who is celebrated as the father of modern empirical chemistry.
On 2007, PAREXEL International Corporation announced the successful completion of the acquisition of Taiwan-based APEX International Clinical Research Co., Ltd. ("APEX". The acquisition strengthens PAREXEL's global capabilities, providing clients with a wide range of clinical research service offerings throughout the Asia-Pacific region, including mainland China, Hong Kong, India, Taiwan, Singapore, Indonesia, South Korea, Malaysia, Thailand, the Philippines, New Zealand, and Australia
Growth - Over the last 25 years, PAREXEL has expanded its portfolio of services and global footprint through a combination of organic growth, alliances, and acquisitions, including the purchase of CROs in emerging geographies, in order to provide expanded capabilities for its clients?clinical development programs.
Innovation - PAREXEL has made several innovative contributions to the advancement of the bio/pharmaceutical industry during its history, and was one of the first companies to formally define the contract service provider sector. PAREXEL broke new ground in the early 1980s by conceiving of a highly complex, multi-disciplinary and systems-oriented approach to outsourced clinical development, bringing efficiencies, speed, scalability and standardization to the process. As the industry adopted new software and Internet-based systems, PAREXEL created an industry-leading advanced technology offering. Today, PAREXEL is a front runner in providing eClinical solutions through its subsidiary Perceptive Informatics, Inc.
Focus - PAREXEL has remained focused on its mission to help clients find new ways to prevent and cure disease, contributing to the development and launch of many new drugs and treatments. PAREXEL's experts, who have experience across a broad range of therapeutic areas, have supported nearly all of the top 50 best-selling drugs that are on the market today.
Vision, Mission and what we value
Our Vision
PAREXEL strives to be the premier provider to the bio/pharmaceutical and medical device industries for development and commercialization of new medical therapies worldwide.
Our Mission
PAREXEL's mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.
What we value
• Integrity & Ethics
• Sense of Urgency
As a leading CRO in the Asia-Pacific region, PAREXEL INTERNATIONAL is committed to create a teamwork environment where each employee can be motivated and nurtured both in the personal and professional levels. We provide our employees with necessary assistances, certifications, resources and technical trainings that are crucial to ensure they perform their duties successfully.
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