Überblick über die Statistik des Gehaltsniveaus für "Investigator Support Coordinator in Deutschland"

Location: Italy - home based      Schedule: Full-time, Permanent             CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Clinical Research Associate (CRA II/SCRA).  You will manage clinical projects to ensure quality, budget, and timelines are met while working on projects from our varied client base, ranging from small to mid-sized pharma, biotech, and medical device companies. The studies you will initially be assigned to will be within Oncology, Respiratory, Medical Devices, and Cardiology.                 Join our team and help us deliver clinical trials that will improve patients' lives.               Main Job Tasks and Responsibilities:Keeps professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assignedAssists in the selection of sites, site evaluation visits, initiation visits, and ensuring follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.May act as Feasibility Associate after appropriate and documented training.Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP compliance.Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness, and quality of the Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety.Conducts source data verification and in-house review of clinical data and ensures timely resolution of data queries to guarantee reliable clinical data.Manages the investigational products (storage, inventory, dispensing records, packaging, and labeling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the siteCooperates with the site staff for ensuring proper reporting from the site of the safety issues (such as AEs/SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.Will be the main contact person for the site in order to ensure close follow up.Provides general support to the Clinical Research Division on quality control of clinical data.Promptly address the Projects Coordinators/ Project Managers/ Senior Project Managers about any issues that can jeopardize the conduct of the clinical projects assigned.Reports to the Head of Clinical Monitoring Unit on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed for each single clinical trial.Develops training material and gives training in collaboration with the Training & Qualification Management UnitMay assist in contract negotiation with sites on study budget after appropriate and documented training.Assists the preparation of the study including CRF design/development, writes CRF instructions, and organizes the study files and documents to ensure good start-up of the investigation sites.May support the submission process in the project (or region), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training.Guides and supervises Clinical Research Associate I (CRA I) in order to coach and train them on the job. Education and Experience:University Degree in scientific medical or paramedical disciplinesPrevious proven experience as a CRA, performing on-site monitoring activitiesStrong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements Specific Role Requirements and Skills:Fluent in EnglishProficiency in Microsoft Office (e.g. Word, Excel, Outlook)Willingness to travel The Benefits of Working in Italy:Meal vouchersMobile phone if requested by the Line ManagerDedicated Line ManagerMonthly meetings with the line managerFull performance and development process with end-of-year reviewsTeam events and end-of-year partyCareer opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationallyEmployee satisfaction survey - your feedback is important for continuous improvement. The Application Process      Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step. If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact mailto:[email protected] for more information.             Who will you be working for?             About CROMSOURCE         CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                            Our Company Ethos      Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.       CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.             Keywords: Clinical Research Associate, CRA, Site Management, Monitor, Monitoring, Oncology, Respiratory, Medical Device, Cardiology, Travel, Submissions, Ethics, Contract Research Organisation, CRO, Permanent, Pharma, Outsourcing.Skills: Cardiology, Oncology, Respiratory, Clinical Research Associate, clinical trials, CRO, Medical Devices, Monitoring, PharmaLocation: ItalyShare: LinkedIn Facebook Twitter Email

Open for hire at one of the following locations – Mainz Goldgrube, Cambridge, Gaithersburg, London. - Job ID: 6298 Become a member of the BioNTech Family!As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history. We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives. (Senior) Manager* Clinical Trials Your main responsibilities are: Independently leading a cross functional team for study execution for one or several studies. May also support a Assoc. Director on this activity or may be responsible for a smaller programResponsible for defining and implementing the study quality standards and study objectives as agreed with the program teamResponsible for Vendor oversight and issue resolution/escalation for the responsible studiesResponsible for ensuring study timelines are per plan or mitigations are introduced to limit timeline shiftsWork with cross functional team and the CRO to prepare and compile documents for ethics committee and health authority submission and study plansPlanning, review, and conduct of training sessions relevant to the studies as well as team and investigator meetings/PSVs/SIVsDelegation and supervision of one or more clinical trial specialists assigned to the studiesPreparation and presentation of Study status, risks, and mitigations to management and the cross functional teams What you have to offer: A bachelor’s degree in the life sciences or a university degree with experience in a health professionMinimum 5 years of professional experience as a Clinical Study Manager, CRA/Clinical Monitor or in a similar function, with at least 3 years managing a cross functional team for study execution (Phase 1-3)Experienced in managing vaccine studies is a plusExperienced in managing studies in Sub-Saharan Africa is a plusVery good knowledge of relevant laws and regulations (e.g. ICH GCP guideline)Proactive, independent way of working as well as excellent communication and organizational skills Benefits for youBioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.Click here to find out more about what we do, the careers we offer and also the benefits we provide.Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law. Have we kindled your pioneering spirit? This vacancy is to be hired at one of the following locations – Mainz Goldgrube, Cambridge, Gaithersburg, London. Apply now for your preferred job and location through our careers site.*BioNTech does not differentiate on the basis of race, colour, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, veteran status, genetic information, or any other characteristic protected by applicable law. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!Über das Unternehmen:BioNTech

Abiomed is an innovative medical device business with an inspiring mission "Patients First" and a unique guiding company principle "Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson MedTech.Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.Clinical Trial CoordinatorThe Clinical Trial Coordinator (CTC) supports Clinical Project and Program Managers in planning and coordinating activities in all aspects of clinical trial operations. This position requires appropriate interpretation of significant policies and procedures. It involves interaction with internal and external customers and partners, and must operate with a high degree of discretion, as the role involves handling information of a confidential and critical nature.Main tasks and responsibilities:Plan, coordinate, and arrange study communications and meetings on and off-site with both internal and external attendeesPrepare all necessary documents for the evaluation of new proposals and coordinate the decision process of new AR or ISS projectsManage the grant application platform which maintains all necessary documents and the communication with PIsSet up, update, maintain and close Trial Master Files. Assure currency and accuracy of required clinical trials documents Maintain project-specific regulatory document inventory systems which include a precise quality check (QC) process when documents are receivedCommunicate with investigator sites on collection of regulatory documentsCreate study materials, including newsletters, study updates, etc. under the direction of a Scientist or Clinical Program ManagerSource and distribute study suppliesInteract with Finance departments to support invoice processingInteract with the Sales and Customer service department to support and coordinate external needs and internal processes.Under guidance of Clinical Operations management, interact with internal stakeholders and external clients to coordinate the accomplishment of business needsRequirements:BS degree or BS degreeRelevant clinical or basic research experience working at an Investigator Site, Sponsor or Clinical Research OrganizationFamiliarity of clinical trial operations, ICH, GCP Guidelines Good working experience in a team environment across multi-functional areasHighly organized, self-motivated, detail-oriented, proactive, and accurateAbility to work with urgency and thrive in a high-energy, fast-paced environmentDemonstrate excellent communication, verbal and written, and interpersonal skillsFluent in written and spoken English and GermanDemonstrate proficiency in MS Office Suite: Word, PowerPoint, Excel, Project ABIOMED is an Equal Employment Opportunity employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, disability or national origin. Über das Unternehmen:Johnson and Johnson

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.What you will be doing: Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country(ies) Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training Oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning Communicate country status (including timelines and deliverables) to key stakeholders (e.g., GCMs, Program Managers, CST or TMT, Contribute and develop to program,/study-specific materials - e.g., monitoring plan, study specific training documents. Support and contribute to Clinical Study Teams (CSTs) / Trial Management Teams Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through Maintain expert country, site and protocol knowledge to support sites with questions as well as build strong site relationships. Partner with global, local country teams and study team to provide high level country strategy, drive study progress and country level Maintain the quality and scientific integrity of clinical trials at a country level. Collaborate with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial. Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out at a country level in accordance with ICH-GCP and other applicable local regulations deliverable within the country study delivery. (Accountable for study deliverables and drives key decisions within set country) leadership of the cross-functional Local Study Team (LST) Supports country-level operational planning and accountable for site selection within assigned country(ies) (TMTs) as applicable, agenda driven, present at meetings. DOM etc) with oversight as required and ensures updates to relevant systemsEngage with local cluster team and local functions from a study perspective (e.g., Local Medical, DOM). Accountable for approval of Baseline and Revised Enrolment Plans (Country Level) assigned countries, management of ELE (enrolment long-range estimates)process Monitor the execution of the clinical study against timelines, deliverables, and budget for that country: Translate global start up requirements into local country targets Monitor country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment and retention strategic solutions. Monitor and act upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate Review Monitoring Visit Reports Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation across You are:A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.Minimum two to four years clinical trial management experience Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Good written and oral communication skillsWhat ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include: Various annual leave entitlementsA range of health insurance offerings to suit you and your family’s needsCompetitive retirement planning offerings to maximise savings and plan with confidence for the years aheadGlobal Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-beingLife assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among othersVisit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, 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, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.