Cra
vor 2 Monaten
Clinical Research Associate OR Senior Clinical Research Associate
- Development Monitoring Excellence Academy (MEA) training program
- Provide clinical support for projects according to Labcorp Drug Development Standard Operating Procedures, ICH Guidelines and GCP
- Develop and/or maintain tracking systems for clinical projects
- Assist teams and conducts site monitoring of clinical research studies according to Labcorp Drug Development Standard Operating Procedures, ICH Guidelines and GCP
- Site management responsibility for clinical studies according to Labcorp Drug Development Standard Operating Procedures, ICH Guidelines and GCP
**Essential Job Duties**
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance (as per the training status of the CRAI-MEA); liaise with vendors; and other duties, as assigned
- Responsible for aspects of registry management as prescribed in the project plans
- General On-Site Monitoring Responsibilities:
- Assist Senior CRAs and CRA-2 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)
- Initiate, monitor and close out clinical investigative sites, with or without direct supervision from Senior Clinical Research Associates, Clinical Team Leads, Project Managers or Project Directors, as assigned based on training status and adequate skillset acquisition. On-site Routine Monitoring Visits should be accompanied by an experienced co-monitor (as per training status and agreement from Line Management).
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection
- tools by careful source document review
- Monitor data for missing or implausible data
- Ensure the resources of the Sponsor and Labcorp Drug Development are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp Drug Development travel policy
- Travel, including air travel, may be required as per essential job functions.
- Prepare accurate and timely trip reports
- Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Labcorp Drug Development or client data management systems, as assigned by management
- Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
- Provide coverage for clinical contact telephone lines, as required
- Update, track and maintain study-specific trial management tools/systems
- Generate and track drug shipments and supplies, as needed
- Track and follow-up on serious adverse events as assigned
**Experience**
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure) and minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)
- Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP
- Ability to work within a project team
- Good planning, organization and problem solving abilities
- Good communication skills, oral and written
- Good computer skills
- Works efficiently and effectively in a matrix environment
- Fluent in local office language and in English, both written and verbal
**Education/Qualifications/Certifications and Licenses**
- Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements
- Basic understanding of the clinical trial process
- Valid Driver’s License
**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more informa
Wir haben weitere aktuelle Stellen in diesem Bereich, die Sie unten finden können
-
Cra/scra Switzerland
vor 2 Wochen
Zurich, Schweiz Fortrea - Organic VollzeitAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Cra/scra Switzerland
vor 2 Monaten
Zurich, Schweiz Labcorp VollzeitAssures the implementation of project plans as assigned - Site administration and site monitoring responsibility for clinical studies according to Labcorp Drug Development Standard Operating Procedures, ICH Guidelines and GCP - Site management responsibility for clinical studies according to Labcorp Drug Development Standard Operating Procedures, ICH...
-
Associate/consulting Associate
vor 2 Monaten
Zurich, Schweiz Charles River Associates - Recruiting Vollzeit**About Charles River Associates**: For over 50 years, Charles River Associates has been a premier consulting firm that offers employees a place to learn from a diverse group of consultants, industry experts, and academics. At CRA you will be exposed to leading minds who use economic, financial, and business analysis to solve complex problems for an...
-
Clinical Project Leader
vor 3 Wochen
Zurich, Schweiz Proclinical VollzeitProclinical have partnered with a mid-sized Biotech who are recruiting for a Clinical Trial Leader. They have had several successful product launches over last few years and are presently running multiple phase III trials within highly multifaceted therapy areas. You will be responsible leading a phase III pivotal study in Neuroscience handling...
-
Clinical Project Manager
vor 2 Wochen
Zurich, Schweiz BIOTRONIK VollzeitClinical Project Manager BIOTRONIK is one of the leading manufacturers of cardio - and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology...
-
Zurich, Schweiz Takeda Pharmaceutical VollzeitOur team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?** - **Location: EUCAN (Europe and Canada). Open to any of our office locations across the region.** The main purpose of this role is to shape the scientific understanding and narrative for TAK755 in Europe and Canada, by interacting with the...
