CLINICAL RESEARCH ASSOCIATE/SENIOR CLINICAL RESEARCH ASSOCIATE

2 weeks ago

Boston MA USA, United States Edgewise Therapeutics Full time
Clinical Research Associate/Senior Clinical Research Associate

About Edgewise Therapeutics

At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.

We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients

About the Position:

This is a remote position for a growing Clinical Development. The assigned clinical trials will be highly complex and high risk, e.g., multiple indications, data monitoring committees, interim analyses, adaptive design, requiring the coordination of multiple vendors, or other special assessments. Candidate may be asked to provide support to clinical study lead for more than one study or across programs.

Essential Job Duties and Functions:

* Accountable for study and site level tracking e.g., patient visits, invoices, and IRB submissions
* Supports patient enrollment activities and deliverables.
* Participate in country and site feasibility/selection process.
* Acts as QC of Trial Master Files; review of TMF index.
* Accountable for ensuring that agendas for meetings are clear and distributed in advance; takes comprehensive and precise minutes for internal and external meetings.
* Proactively identifies potential operational challenges and in collaboration with senior team members, provides solutions to ensure study execution remains on track.
* May participate in review of data listings to identify trends.
* Support the oversight of vendors at the direction of the study lead.
* Participation in the development of patients and site facing documents.
* Maintains internal Clinical Operations databases and document repositories.
* Assist with administration and management of site and vendor invoices, including invoice reconciliation for clinical trial operations.
* Assist with site start-up activities, e.g. essential document package review, site initiation slide decks
* Oversight of CRO monitoring activities (e.g., visit schedules, monitor visit reviews, reviewing monitoring plant.
* Review of relevant study-specific plans and/or processes, as applicable
* Document review and monitoring of risks and decisions at the study level and implementation of mitigation strategies.
* Participates in the review of database CRFs and user acceptance testing.
* Ensure studies are inspection ready at all times; may be involved in regulatory inspections by preparing for and attending the inspections.
* Help with onboarding and mentoring of new department members.
* Adheres to Clinical Operations processes and SOPs.
* Read, understand, and comply with all workplace health and safety policies, safe work practices; and company policies and procedures.
* Perform other duties as assigned by supervisor.

Required Education, Experience and Skills:

* At least 2+ years of relevant experience and a BS or BA (Life Sciences)
* Clinical trial experience in the pharmaceutical or health care industry or equivalent
* Excellent attention to detail, verbal, written, interpersonal and presentation skills are required.
* Must be familiar with routine medical/scientific terminology.
* Proficiency with MS Office
* Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
* Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision.
* High energy level, personal productivity, creativity, and commitment
* Team-player desiring to work in a fast-moving, dynamic start-up environment

Salary range: $75,000-$145,000, title and salary commensurate with experience

Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.

There is no deadline because the employer accepts applications on an ongoing basis.

Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.

  • Clinical Research Coordinator I

    4 weeks ago

    Boston, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionClinical Research Coordinator IThe CRC I will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds...

  • CLINICAL RESEARCH NURSE

    1 week ago

    Wildwood, MO 63005, USA, United States Headlands Research Full time

    OverviewClinical Research Professionals (CRP) is a dedicated research center that provides a network of physicians who work collaboratively in conducting clinical research trials. Our team consists of experienced research professionals helping to improve lives through the advancement of new drug therapies and medical devices. We have recently partnered with...

  • Clinical Research Associate

    2 weeks ago

    Boston, United States Elucid Full time

    Are you working in a job that is making a difference for millions of people? If not, keep reading to learn more about Elucid. We are a rapidly growing, Boston-based medical technology company using AI to help clinicians make more informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare...

  • Clinical Research Associate

    2 weeks ago

    Boston, United States Elucid Full time

    Are you working in a job that is making a difference for millions of people? If not, keep reading to learn more about Elucid. We are a rapidly growing, Boston-based medical technology company using AI to help clinicians make more informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare...

  • Assistant/Associate Editor

    2 weeks ago

    Boston, Massachusetts, United States American Association for Cancer Research Full time

    Overview: About Cancer Research Communications: Launched in 2021, Cancer Research Communications is the AACR’s open access journal and the newest member of the AACR journal ecosystem, publishing high-quality original research articles that report information of value to the cancer research community in a timely and rigorous fashion. The journal’s scope...

  • Research Associate

    4 weeks ago

    Boston, United States Lux Research, Inc. Full time

    Job DescriptionJob DescriptionDescription:Lux Research, a pioneer in the realm of sustainable innovation, is actively searching for a Research Associate (RA) poised to contribute to the very heart of our mission. This role is crafted for individuals who are not only adept in generating pivotal research but also possess an innate ability to dive deep into the...

  • Clinical Research Coordinator

    2 weeks ago

    Boston, United States Partners Healthcare System Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT: The mission of our laboratory is to improve the quality of life for patients with celiac disease and other gluten-related disorders. The successful candidate will serve as a Clinical Research Coordinator in our center and gain interdisciplinary research experience through assisting with the conduct and management of...

  • Clinical Research Associate Manager---Cancer Center Protocol Office

    1 week ago

    Boston, MA, United States Mass General Brigham Full time

    DescriptionGENERAL SUMMARY/ OVERVIEW STATEMENT:The Clinical Research Associate Manager works under direct supervision of a more experienced manager. The Clinical Research Associate Manager provides first-line supervision to Clinical Research Coordinators (CRC) and oversees the day-to-day operations of the staff while maintaining some CRC responsibilities and...

  • Research Associate

    2 weeks ago

    Boston, United States Gardner Resources Consulting Full time

    Our Life Sciences client located in the Boston, MA area is currently searching for a Contract Research Associate to assist with ad hoc projects related to assay development for their Research & Innovation Team. The Clinical Research Associate will design, implement, analyze, and troubleshoot experiments while maintaining SOP's and will collaborate with...

  • Associate, Research

    1 week ago

    Boston, United States Lux Research, Inc. Full time

    Job DescriptionJob DescriptionDescription:Lux Research, a distinguished research and advisory leader in the realm of sustainable innovation, is on the hunt for a visionary and detail-oriented expert in agriculture technologies capable of impacting the Consumer Products (CPG) space to elevate our Lux Expertise team. We're inviting an experienced...

  • Senior Clinical Trials Manager

    3 weeks ago

    Boston, United States Clinical Dynamix Full time

    The Senior Clinical Trials Manager is responsible for leading the execution of clinical studies on schedule and on budget. Senior CTM level reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs. This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid...

  • Senior Clinical Research Coordinator

    2 weeks ago

    Boston, United States Massachusetts General Hospital Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT: Under the general supervision of the Principal Investigator (PI), the Senior Clinical Research Coordinator will provide clinical translational research assistance for clinical research protocols, including study management, study oversight and study implementation for research conducted as part of the Center for...

  • Senior Clinical Research Coordinator

    6 hours ago

    Boston, United States Brigham & Women's Hospital - Brigham Health Full time

    The Men's Health: Aging and Metabolism Clinical Research Unit at Brigham and Women's Hospital conducts government and industry sponsored clinical trials, covering a wide range of therapeutic areas, with study populations that include both women and m Clinical Research, Research Coordinator, Clinical, Research, Coordinator, Senior, Healthcare

  • Senior Clinical Research Coordinator

    2 weeks ago

    Boston, United States Massachusetts General Hospital Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT: The Senior Clinical Research Coordinator (Sr. CRC) works independently under minimal supervision to support the team by maintaining clinical research collection protocols. The Sr. CRC will ensure timely collection of protocol related samples and ensure study compliance with all state, federal, and IRB requirements. In...

  • Research Associate

    4 weeks ago

    Boston, United States Lux Research, Inc. Full time

    Job DescriptionJob DescriptionDescription:Lux Research, a pioneer in the realm of sustainable innovation, is actively searching for a Research Associate (RA) poised to contribute to the very heart of our mission. This role is crafted for individuals who are not only adept in generating pivotal research but also possess an innate ability to dive deep into the...

  • Research Associate, Industrials

    4 weeks ago

    Boston, United States Lux Research, Inc. Full time

    Job DescriptionJob DescriptionDescription: Lux Research, a pioneer in the realm of sustainable innovation, is actively searching for a Research Associate (RA) poised to contribute to the very heart of our mission. This role is crafted for individuals who are not only adept in generating pivotal research but also possess an innate ability to dive deep into...

  • Research Associate

    5 hours ago

    Boston, United States Lux Research, Inc. Full time

    Job DescriptionJob DescriptionDescription:Lux Research, a pioneer in the realm of sustainable innovation, is actively searching for a Research Associate (RA) poised to contribute to the very heart of our mission. This role is crafted for individuals who are not only adept in generating pivotal research but also possess an innate ability to dive deep into the...

  • Research Associate

    2 weeks ago

    Boston, United States Lumanity Full time

    Overview / About us Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances. We partner with life sciences companies around the world to generate evidence to demonstrate the value of their product, translate the science and data into compelling product narratives, and enable commercial decisions that...

  • Clinical Research Coordinator

    2 weeks ago

    Boston, United States Partners Healthcare System Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT: The Pediatric Neuropsychiatry and Immunology Program (PNIP) at Massachusetts General Hospital is looking for a clinical coordinator to assist with research focused on pediatric Obsessive-Compulsive Disorder (OCD) and Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal infection (PANDAS). Under...

  • CLINICAL TRIAL RESEARCH NURSE

    1 week ago

    Chicago, IL, USA, United States Alliance for Clinical Trial in Oncology Foundation Full time

    The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the...