Clinical Trial Associate/Sr. Clinical Trial Associate
4 weeks ago
Company Overview
Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to symptoms and functional deficits. Our lead investigational product candidate, ninerafaxstat, has completed Phase 2 clinical trials in non-obstructive hypertrophic cardiomyopathy (nHCM), stable angina, and in patients at high risk of developing cardiometabolic heart failure with preserved ejection fraction (pre-HFpEF). In Phase 1 and 2 clinical trials, ninerafaxstat was shown to be well tolerated. Part 2 of our Phase 2 trial, IMPROVE-DiCE, in patients with cardiometabolic HFpEF, is ongoing with topline results expected in early 2025. For additional information, please visit www.imbria.com.
Position Overview
The CTA is responsible for supporting the daily workflow of clinical operations activities. The CTA provides administrative support to study teams throughout the study. Key activities include, but are not limited to, managing meeting materials, review of study documents particularly during study start-up, maintaining study trackers, and oversight of the study-specific eTMF and other administrative upkeep. Note: This position requires the incumbent to reside in the Boston area.
Responsibilities
- Serves as a member of the clinical operations team and provides administrative support and tracking of trial status, with the goal to contribute towards efficient management of trials
- Collaborates with CRO and vendor partners on start-up activities, providing oversight of site initiation, reviewing essential documents, providing authorization of clinical sites to receive investigational product, assisting in providing access to study eSystems, etc., in coordination with Clinical Trial Manager (CTM)
- Administrative upkeep of clinical studies, including development of documents, review, and coordination of broader team review of CRO or vendor-generated material, tracking and distribution of study documents, drafting/review of meeting minutes
- Support CTM in build of study eSystems and subsequent User Acceptance Testing
- Provide oversight and quality checks of CRO-managed Trial Master File
- Track and reconcile clinical trial equipment, samples, imaging files, etc.
- Support invoice and budget activities including review and tracking of vendor invoices against contracts with oversight of CTM
- Assisting CTM with site management activities, including review of monitoring reports, tracking of performance metrics, risk identification and mitigation, etc.
- Provides administrative support to the clinical study team for study related activities (e.g. maintenance of study mailbox, newsletter creation/review, study document formatting, binders, meeting minutes etc.)
- Assists in planning and organizing project-specific meetings including but not limited to internal clinical study team meetings, external service provider/partner meetings, CRA training, Investigator Meeting and PI meetings. Creates agendas, meeting minutes, and distributes.
- May act as point of contact for study-related requests for team members and service providers/partners
- May support the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan
Qualifications
- Bachelors degree required, preferably in the Life Sciences or equivalent
- Minimum of 3 years of clinical research experience or proven competencies for this position, prefer experience in a clinical research related position within the biotech, pharmaceutical or medical device industry
- Must have established experience and fluency in the Microsoft Office package of programs (Excel, Word, Outlook, PowerPoint, SharePoint)
- Prior experience with clinical trial start-up in global studies preferred
- Familiarity with ICG/GCP, and FDA requirements governing clinical trial management
- Proven ability to work independently and prioritize tasks effectively in a fast-paced, remote working environment
- Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders
- Communicates both verbally and in written form in an efficient and professional manner
- Demonstrates values and a work ethic consistent with Company Values
- Exhibits high self-motivation, is detail-oriented, and able to work and plan independently as well as in a team environment
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient
This position requires the incumbent to reside in the Boston area. We offer a competitive total compensation package and invite you to consider a career with Imbria
-
Clinical Trial Manager
1 week ago
Boston, United States Clinical Dynamix Full timeResponsible for oversight, coordination, and execution of clinical trials in support of clinical operations programs in Phases I‐IV of development.RESPONSIBILITIESClinical Operations team member: works closely with the Sr. CTM and/or Director of Clinical Operations and is responsible for oversight, planning, and execution of assigned clinical studies,...
-
Clinical Trial Manager
13 hours ago
Boston, United States Clinical Dynamix Full timeResponsible for oversight, coordination, and execution of clinical trials in support of clinical operations programs in Phases I‐IV of development.RESPONSIBILITIESClinical Operations team member: works closely with the Sr. CTM and/or Director of Clinical Operations and is responsible for oversight, planning, and execution of assigned clinical studies,...
-
Clinical Trial Associate 1
2 weeks ago
Boston, United States Xenon Pharmaceuticals Inc. Full timeWho We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Clinical Trial Associate 1
1 day ago
Boston, United States Xenon Pharmaceuticals Inc. Full timeWho We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Clinical Trial Associate 1
2 weeks ago
Boston, United States Xenon Full timeWho We Are:Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Clinical Trial Associate 1
17 hours ago
Boston, United States Xenon Full timeWho We Are:Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Sr. Clinical Trial Associate
2 weeks ago
Boston, United States Planet Pharma Full timeMUST HAVEStudy Start upSponsor / Biotech (HIGHLY Preferred)TMF spot check Reviewed monitoring reportsTracking documents for review from CROReview of Pharmacy ManualAble to perform preliminary document reviewHighly Organized and "on the ball"Role summaryThe CTA/ iCRA, reporting to the Director, Clinical Operations, will be responsible for supporting the...
-
Sr. Clinical Trial Associate
2 weeks ago
Boston, United States Planet Pharma Full timeMUST HAVEStudy Start upSponsor / Biotech (HIGHLY Preferred)TMF spot check Reviewed monitoring reportsTracking documents for review from CROReview of Pharmacy ManualAble to perform preliminary document reviewHighly Organized and "on the ball"Role summaryThe CTA/ iCRA, reporting to the Director, Clinical Operations, will be responsible for supporting the...
-
Sr. Clinical Trial Associate
3 weeks ago
Boston, United States Planet Pharma Full timeMUST HAVEStudy Start upSponsor / Biotech (HIGHLY Preferred)TMF spot check Reviewed monitoring reportsTracking documents for review from CROReview of Pharmacy ManualAble to perform preliminary document reviewHighly Organized and "on the ball"Role summaryThe CTA/ iCRA, reporting to the Director, Clinical Operations, will be responsible for supporting the...
-
Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
-
Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
-
Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
-
Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
-
Senior Clinical Trial Associate
1 week ago
Boston, United States Entrada Therapeutics Inc. Full timeThe Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV)-therapeutics are designed to enable the...
-
Senior Clinical Trial Associate
1 week ago
Boston, United States Entrada Therapeutics Full timeThe Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the...
-
Senior Clinical Trial Associate
4 hours ago
Boston, United States Entrada Therapeutics Full timeThe Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the...
-
Senior Clinical Trial Associate
1 week ago
Boston, United States BioSpace Full timeJob DetailsThe Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable...
-
Senior Clinical Trial Associate
1 day ago
Boston, United States BioSpace Full timeJob DetailsThe Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable...
-
Senior Clinical Trial Associate
3 days ago
Boston, United States Kura Oncology, Inc. Full timeAre you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the science of...
-
Senior Clinical Trial Manager
1 week ago
Boston, United States Argenx SE Full timePURPOSE OF THE FUNCTION The Senior Clinical Trial Manager (CTM) is responsible for all operational aspects of the assigned clinical studies from monitoring initiation till closure of the studies. The successful candidate will have clinical trial operational experience in phase I, II and III drug development phases and is an operational expert in the...
