Clinical Trial Coordinator
1 month ago
Job Description
At Thermo Fisher Scientific, youâll 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 through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on â now and in the future.
Job description:
Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents CRG personnel. May act as a buddy during onboarding phase and provide training to new staff as needed.
· Mainly responsible for IRB submission including but not limited initial, amendment and safety submission.
· According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
· Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads.
· Provides system support (i.e., CTMS & eTMF) and ensures system databases are always current.
· Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
· Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
· Assists with study-specific translation materials and translation QC upon request.
· Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
· Where applicable, conducts on-site feasibility visits (Asia Pac only).
· May support scheduling of client and/or internal meetings.
· May provide system support (i.e. eTMF).
· Transmits documents to client and centralized IRB/IEC.
· Maintains vendor trackers.
· Supports start-up team in IRB submissions.
· Works directly with sites to obtain documents related to site activation. Assists the project team with the preparation of regulatory compliance review packages.
· Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned..
· Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel
regarding site issues and risks.
· Ensures an efficient, effective plan is in place for site contact and follow up.
· Ensure compliance with the plan and escalate concerns/non-compliance to management.
· May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites.
· Trains new personnel in processes and systems.
Requirements:
- Minimum bachelor degree (major in nursing, pharmacy or other science-related background)Â
- At least 1 year working experience in the clinical research industry as a CTC or submission specialist in global pharma or CRO.
-
Clinical Trial Coordinator
4 weeks ago
Taipei City, Taiwan MSD Full timeJob DescriptionUnder the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.The...
-
Clinical Study Administrator
1 week ago
Taipei, Taiwan Parexel Full timeJob DescriptionMajor Duties of CTA: Support the tasks below for assigned project throughout the study:o Requests payments for study related costo Updates the trial and site information as necessary in Corporate Clinical Trial Registry (CCTR) in a timely mannero Attends appropriate training programs and project teleconferences as applicable.o Maintains the...
-
Clinical Study Administrator
1 week ago
Taipei, Taiwan Parexel Full timeJob DescriptionMajor Duties of CTA: Support the tasks below for assigned project throughout the study:o Requests payments for study related costo Updates the trial and site information as necessary in Corporate Clinical Trial Registry (CCTR) in a timely mannero Attends appropriate training programs and project teleconferences as applicable.o Maintains the...
-
Clinical Operation Director
3 weeks ago
Taipei, Taiwan Fyte Full timeSummary:The Clinical Operations Director plays a crucial role in overseeing and managing all aspects of clinical operations within a CRO. This position involves strategic planning, leadership, and coordination to ensure efficient and successful execution of clinical trials in accordance with regulatory requirements, timelines, and quality...
-
Clinical Project Manager
3 weeks ago
Taipei, Taiwan Fyte Full timePosition Overview:We are seeking a highly motivated and experienced Clinical Project Manager to join our team. The Clinical Project Manager will be responsible for the overall management and execution of clinical trials, ensuring compliance with regulatory requirements, timelines, and budget constraints.Key Responsibilities:Manage all aspects of clinical...
-
Trial Programmer Manager
3 weeks ago
Taipei City, Taiwan Thermo Fisher Scientific Full timeJob DescriptionManages a small team within the department who are responsible for the bioinformatics programming aspects of clinical trials from design through analysis and reporting. Acts as the lead programmer, project lead, or project oversight lead of a client/asset on multiple projects, able to oversee both the statistical as well as programming aspects...
-
Trial Programmer Manager
3 weeks ago
Taipei City, Taiwan Thermo Fisher Scientific Full timeJob DescriptionManages a small team within the department who are responsible for the bioinformatics programming aspects of clinical trials from design through analysis and reporting. Acts as the lead programmer, project lead, or project oversight lead of a client/asset on multiple projects, able to oversee both the statistical as well as...
-
Clinical Operation Director
2 weeks ago
Taipei, Taiwan Fyte Full timeGeneral Statement: The Clinical Operations Director is responsible for the leadership and oversight of development and implementation of clinical programs and pull-through projects. The position includes strategic input to company's assets, programs, and database development while working closely with clinical, business development, and other relevant...
-
Clinical Operation Manager
4 weeks ago
Taipei City, Taiwan MSD Full timeJob DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.This role is accountable for performance and compliance for...
-
Associate Clinical Research Associate
2 weeks ago
Taipei City, Taiwan MSD Full timeJob Requirements The opportunitiesAs a ACRA or CRA, you will be accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager, you will ensure compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting...
-
Clinical Research Associate
2 weeks ago
Taipei, Taiwan Parexel Full timeWhat you'll do: -Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports. -Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff....
-
Clinical Research Associate I
4 weeks ago
Taipei, Taiwan Parexel Full timeKey Accountabilities:Start-up (from site identification through pre-initiation):Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.Build relationships with investigators and site staff.Conduct, drive and manage country specific feasibility and/or site pre-qualification and...
-
Senior Clinical Research Associate
3 weeks ago
Taipei, Taiwan Parexel Full timeKey Accountabilities:Start-up (from site identification through pre-initiation):Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.Build relationships with investigators and site staff.Conduct, drive and manage country specific feasibility and/or site pre-qualification and...
-
Clinical Research Associate
3 weeks ago
Taipei, Taiwan Parexel Full timeWhat you’ll do: -Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports. -Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff....
-
Medical Director
2 weeks ago
Taipei, Taiwan Fyte Full timeResponsibility: * The MD will play a critical role to identify market trend, unmet medical needs, new indications and plan clinical science strategy. * The person needs to be passionate about medical and drug science research. * Provide medical expertise supporting clinical development activities to ensure optimal clinical development and commercial...
-
Oncology Site Monitor II(FSP)
3 weeks ago
Taipei, Taiwan Parexel Full timeJob DescriptionKey Accountabilities:Start-up (from site identification through pre-initiation:Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.Build relationships with investigators and site staff.Conduct, drive and manage country specific feasibility and/or site pre-qualification...
-
Oncology Site Monitor II(FSP)
3 weeks ago
Taipei, Taiwan Parexel Full timeJob DescriptionKey Accountabilities:Start-up (from site identification through pre-initiation:Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase. Build relationships with investigators and site staff. Conduct, drive and manage country specific feasibility and/or site pre-qualification...
-
Medical Director
2 weeks ago
Taipei, Taiwan Fyte Full timeResponsibility: The MD will play a critical role to identify market trend, unmet medical needs, new indications and plan clinical science strategy. The person needs to be passionate about medical and drug science research. Provide medical expertise supporting clinical development activities to ensure optimal clinical development and commercial positioning...
-
Site Monitor II(FSP)
2 weeks ago
Taipei, Taiwan Parexel Full timeJob DescriptionKey Accountabilities:Start-up (from site identification through pre-initiation:Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase. Build relationships with investigators and site staff. Conduct, drive and manage country specific feasibility and/or site pre-qualification...
-
Study Start-Up Manager
1 week ago
Taipei, Taiwan Parexel Full timeKey Accountabilities:Start-up (from site identification through pre-initiation):Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.Build relationships with investigators and site staff.Conduct, drive and manage country specific feasibility and/or site pre-qualification and...