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Clinical Trial Administrator (CTA)
Gelesis is developing a novel hydrogel platform technology to treat overweight and obesity and chronic diseases related to the GI pathway. Gelesis’ proprietary approach is designed to act mechanically in the GI pathway to potentially alter the course of certain chronic diseases. In April 2019, Gelesis received FDA clearance for its lead product candidate, Plenity™, as an aid for weight management in overweight and obese adults with a Body Mass Index (BMI) of 25-40 kg/m2, when used in conjunction with diet and exercise. Plenity is currently available in limited supply in the U.S. Additionally, Gelesis is developing its second investigational candidate, Gelesis200, a hydrogel optimized for weight loss and glycemic control in patients with type 2 diabetes and prediabetes. Novel hydrogel mechanotherapeutics based on the Gelesis platform technology are also being advanced in other GI inflammatory conditions, such as non-alcoholic steatohepatitis (NASH) and Chronic Idiopathic Constipation (CIC).
Gelesis was also named one of Fast Company’s Most Innovative Companies for 2020.
The Gelesis executive and advisory team includes some of the world’s leading experts in obesity, materials science, chronic disease research, and commercialization. Gelesis was co-founded by PureTech Health (LSE: PRTC). For more information, visit gelesis.com or connect with us on Twitter @GelesisInc.
Clinical Trial Associate (CTA)
Reporting directly to the Sr. Director of Clinical Operations, the Clinical Trail Associate (CTA) will support the clinical operations team in the management, planning, and execution of clinical trials, including administrative aspects in the execution and management of clinical trials creating and overseeing tools for tracking of trial status, documentation, etc.
Clinical Operations Specific
- Conducts all tasks in accordance with applicable Company Policies, Guidelines, Quality Documents, Standard Operating Procedures (SOPs), Working Instructions (WIs), and other Guidance and Standards, as well as current Good Clinical Practice (ICH-GCP) and applicable national regulations
- Support CTM with distributing, requesting, collecting, and reviewing site regulatory documents for the applicable phase of the clinical study (Study Start Up, Enrollment, Follow-Up, Maintenance, etc.). including a precise quality check (QC) when documents are received.
- Ensure central and site file documentation is appropriately tracked and filed, e.g. TMF. Support the clinical operations team in ensuring that documentation complies with ICH/GCP and project specific requirements.
- Reconcile and inventory study documentation periodically and for archiving at study close-out.
- Utilize specified clinical project systems and tools for documentation and trial management.
- Supports trial management activities including taking meeting minutes/providing agendas to the clinical team, tracking screening/enrollment across all sites, and maintaining study status trackers.
- Support the clinical operations team and liaise with Legal and Finance in the development, execution and maintenance of clinical study contracts and budgets. Report relevant status updates/metrics to the study team as per study-specific requirements.
- Work with CMC and Logistical Supply Chain to initiate study drug shipments to and returns from approved sites.
- Ensure training (including trial specific) is completed per the required timelines and trial needs.
- Assist in developing and implementing process improvement initiatives and in the development of Clinical Operations “best practices.”
- Support clinical operations team in ensuring the trial is consistently inspection-ready
- Ensures that digital clinical applications (e.g. investigator training platform, CTMS, eTMF) are working and maintained properly for each trial and users have the proper access.
- Works with the clinical operations team to ensure all clinical trials listings on clinicaltrials.gov and other relevant clinical trial registries are posted and updated as needed.
- Supports the internal preparations for trial system audits and/or inspections, as applicable
- Perform other clinical administrative duties as needed and requested by the Head of Clinical Operations.
Study Budgets & Financial
- Responsible for the maintenance of Investigator Payments/Vendor payment calculation tool for all accruals and payments at study start and throughout the study
- Responsible to ensure that payments are processed in a timely manner and are tracked, and to provide ad hoc reports to CTM/Trial Team on payments related to: Investigator payments, Vendors e.g. Central Laboratory, Contract Research Organizations (as required)
- Ensure all financial documentation and back-up is audit ready for inspection at all times
- Use and follow Legal Department tools and systems to process and track legal documents from the request phase all the way through final execution and sign off. Includes but not limited to NDAs, SOWs, Contracts, MSAs, etc
- Coordinate Investigator Meetings or support organization, as requested. Ensure correct code of practice is adhered to and relevant information is provided to assist this process.
- Organize meetings, as required (e.g. Advisory Board Meetings, Trial Team meetings, Investigator meetings, Governance Meetings, Departmental Meetings, teleconferences, etc).
- Assist in the development of and or delivery of presentations, as requested
Education and Training
- A Bachelor’s Degree in Science is preferred in relation to health and/or life sciences
- A minimum of 3 years of experience in clinical trial administration
Skills and Abilities
- Strong critical thinking and problem-solving skills
- Excellent communication, problem solving, and presentation skills
- Excellent time management and organizational skills
- Flexible and adaptable to changing project priorities, work assignments and deadlines.
- Detailed oriented
- Experience in working in a fast paced, high-volume & cross functional environment handling multiple tasks
- Reliable, conscientious and discreet
- Proven ability to prioritize and multitask
- Self-motivated, shows initiative, is proactive and able to work independently as well as in a team.
- Strong computer skills including knowledge of Excel, Word, and PowerPoint and working exposure to e.TMF databases
- Flexible to take on other duties as assigned
Gelesis is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, veteran status, a person’s size or weight, or any other status protected under federal, state, or local law.
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