Clinical Research Associate
1 week ago
The Clinical Research Associate is responsible for the monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and company SOPs, to support New Drug Applications.
-
The Clinical Research Associate is responsible for the monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and company SOPs, to support New Drug Applications.
- The CRA will support project teams in the placement, implementation, communication, site management, recruitment and retention (R&R) issue identification and resolution, and activities required at the conclusion of clinical studies, as stipulated in the monitoring plans for assigned projects.
- The CRA will expand his/her responsibilities as directed by the Clinical Research Manager [CRM] or Clinical Project Leader [CPL] to include fostering the development of the monitoring program and/or facilitating the objectives of the clinical project teams. The CRA will also assist the CRM/CPL, as directed, in the training, mentoring and supervision of CRAs, assisting in comonitoring of sites and in completing special projects and assignments to further advance the monitoring program and its contributions to the clinical research department.
- Assist other CRAs with study site issues/concerns/audits with the investigator and independently offer resolution strategies, documenting followup activities/outcomes.
- Lead or facilitate collaborative CRA efforts to meet company objectives by organizing/managing special data collection efforts, present or set up task force, as directed by CRM/CPL.
- Follow the Site Management / Ownership / Partnership model to monitor multiple Phase II, III & IV clinical trial sites, across therapeutic areas. Independently schedule and prioritize workload to meet projected deadlines.
- Provide the following support as directed by the CRM/
CPL:
assist in field monitoring training; conduct and observe site visits during training period; offering experienced counsel on issues related to SOPs, regulations and resolution tactics for site issues/concerns.
- Build regional territory by identifying and maintaining contact with potential (near or long term) research investigators.
- Expand understanding of regulations governing clinical research, beyond FDA regulations and ICH/GCP guidelines, (e.g. international regulatory procedures or high level of proficiency in a specific area, e.g. AE reporting) so as to be a resource for the CRA team.
- Indepth knowledge of FDA regulations and ICH/GCP guidelines
- Excellent interpersonal and communication skills (verbal & written), including proficiency in medical terminology and computer systems
- Ability to work effectively with investigators and other research personnel, maintaining a professional demeanor
- Ability to independently resolve site or study related issues Self motivated; detail oriented; team player; flexible
- Ability to prioritize workload to meet project timelines, while managing multiple protocols across therapeutic areas
- Excellent organizational and time management skills
- Function effectively with high degree of personal accountability
- ACRP CCRA or SoCRA certified
- EDUCATION REQUIREMENTS
- Minimum 2 years industry experience as a CRA, or equivalent; experience in clinical medicine (e.g. nursing, laboratory, radiology, pharmacy) or preclinical area (e.g. pharmacology, toxicology) desired.
- Health related background and BS Degree required.
Benefits of Working in ICON:
- Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture one where we challenge you with engaging work and where every experience adds to your professional development.
- At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career both now, and into the future.
- ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
-
Clinical Research Associate Ii
3 weeks ago
Remote, Canada Syneos Health Clinical Full time**Description** **Clinical Research Associate II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...
-
Clinical Research Associate I
3 weeks ago
Remote, Canada Syneos Health Clinical Full time**Description** **Clinical Research Associate I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...
-
Clinical Research Physician
2 months ago
Remote, Canada Headlands Research Full time**The Role** We are seeking an experienced physician specialist to join our Detroit clinical trials research site for 10 to 20 hours per week. We are seeking a leader to usher us into performing clinical trials in new areas of medicine. Any medical specialty will be considered (rheumatology, dermatology, endocrinology, etc) for this role. Do you want to...
-
Clinical Research Physician
1 week ago
Remote, Canada Headlands Research Full timeThe RoleWe are seeking an experienced physician specialist to join our Detroit clinical trials research site for 10 to 20 hours per week. We are seeking a leader to usher us into performing clinical trials in new areas of medicine. Any medical specialty will be considered (rheumatology, dermatology, endocrinology, etc) for this role. Do you want to spend...
-
Remote, Canada ICON Clinical Research Full timeAs a Sr Clinical Scientist you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing: May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol. As lead, will be responsible for...
-
Remote, Canada ICON Clinical Research Full timeAs a Sr Clinical Scientist you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing: May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol. As lead, will be responsible for...
-
Lead Clinical Research Associate, Clinical
3 weeks ago
Remote, Canada Eupraxia Pharmaceuticals Inc. Full time**Lead Clinical Research Associate, Clinical Operations** **About Us**: We are looking for people that like to be part of a fast-paced, growing company that fosters creative spirit and integrated teamwork and are eligible to work within Canada. The Lead Clinical Research Associate, Clinical Operations will oversee and ensure the appropriate operation and...
-
Clinical Research Associate
3 weeks ago
Remote, Canada ICON Full timeThe Clinical Research Associate is responsible for the monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and company SOPs, to support New Drug Applications. - The Clinical Research Associate is responsible for the monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and...
-
Manager, Study Start Up
3 weeks ago
Remote, Canada ICON Clinical Research Full timeAs a Manager, Study Start- Up you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing: Working directly with Investigative Sites, this role will independently manage and perform activities at a site level associated with study start-up including regulatory document...
-
Manager, Study Start Up
1 month ago
Remote, Canada ICON Clinical Research Full timeAs a Manager, Study Start- Up you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing: Working directly with Investigative Sites, this role will independently manage and perform activities at a site level associated with study start-up including regulatory document...
-
Clinical Lead Ii
3 weeks ago
Remote, Canada Premier Research Full timePremier Research is looking for a **Clinical Lead II** to join our** Clinical Management** team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members...
-
Local Trial Manager
3 weeks ago
Remote, Canada ICON Clinical Research Full timeICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
-
Local Trial Manager
1 month ago
Remote, Canada ICON Clinical Research Full timeICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
-
Clinical Research Associate Ii Oncology
3 weeks ago
Remote, Canada ICON Full timeAs a **Clinical Research Associate I or II,** you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. ICON ISS is searching for oncology focused, bilingual Clinical Research Associate I and/or II’s (CRA II / Field Monitor) in Montreal and Quebec City to work on complex and...
-
Remote, Canada Innovaderm Research Full timeThe Associate Director, Patient Recruitment defines recruitment & retention strategies and tactics, which are site and patient centric, as well as explores and implement innovative patient recruitment and site engagement strategies in close collaboration with both internal and external stakeholders and specialized patient recruitment vendors (when...
-
Manager, Clinical Trial Management/responsable
4 weeks ago
Remote, Canada Innovaderm Research Full time**Manager, Clinical Trial Management, North America** The Manager, Clinical Trial Management, is responsible for the functional management of Clinical Trial Managers within Clinical Operations, to ensure they are adequately trained, managing their performance and meeting project assignment objectives. Acts as a mentor to more junior Clinical Trial Managers...
-
Remote, Canada Innovaderm Research Full time**Manager, Clinical Trial Management, North America** The Manager, Clinical Trial Management, is responsible for the functional management of Clinical Trial Managers within Clinical Operations, to ensure they are adequately trained, managing their performance and meeting project assignment objectives. Acts as a mentor to more junior Clinical Trial Managers...
-
Clinical Research Associate Ii
2 weeks ago
Remote, Canada Precision Medicine Group Full time**Position Summary**: The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going...
-
Clinical Research Associate I or Ii Oncology
4 weeks ago
Remote, Canada ICON Full timeICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
-
Principal Clinical Data Scientist
2 weeks ago
Remote, Canada Syneos Health Clinical Full time**Description** **Senior Clinical Data Scientist** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...