Sr Clinical Research Associate
vor 7 Monaten
**Senior CRA - Germany**
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Our clinical department defines, develops and delivers clinical programmes. Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and implement high-quality, cost-efficient clinical studies.
- The CRA:
- Performs and coordinates all aspects of the clinical monitoring and site management process.
- Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation..
- Ensures audit readiness.
- Develops collaborative relationships with investigational sites.
- Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
A day in the Life:
- Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Assess investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Brings up observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
- May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
- Conducts monitoring tasks in accordance with the approved monitoring plan.
- Participates in the investigator payment process.
- Ensures a shared responsibility with other project team members on issues/findings resolution.
- Investigates and follows-up on findings as applicable
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
- Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS).
- Performs QC check of reports generated from CTMS system where required.
- Participates in investigator meetings as necessary.
- Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Gives to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Gives to other project work and initiatives for process improvement, as required.
**Education and Experience**
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
- Valid driver's license
- Full Right to work in Germany
- Fluency in English and German langua
-
Clinical Research Associate
vor 21 Stunden
Munich, Deutschland Translational Research in Oncology VollzeitIf you are an experienced CRA who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you! - TRIO (Translational Research in Oncology) is an academic clinical research organization that is dedicated to advancing translational cancer research by pursuing forward innovative and targeted...
-
Sr. Clinical Research Associate Ii
vor 21 Stunden
Munich, Deutschland Labcorp VollzeitThe Senior Clinical Research Associate II (Sr CRA II) is responsible and accountable for site monitoring and site management for clinical studies according to Covance, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Sr CRA II assures the implementation of project plans as assigned, functions as leader for projects of limited...
-
(Sr) Clinical Research Associate
vor 7 Monaten
Munich, Deutschland Thermo Fisher Scientific Vollzeit**Work Schedule** Other **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...
-
Freelance Clinical Research Associate
vor 7 Monaten
Munich, Deutschland Talent Source VollzeitDescription: **Location**: Frankfurt/ Munich area, Germany, Home-based **Schedule**: Freelance - 0.5 - 0.7 FTE CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a - **Freelance Clinical Research Associate** In this...
-
Clinical Research Associate 2
vor 6 Monaten
Munich, Deutschland Veranex, Inc. VollzeitVeranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...
-
Clinical Research Associate
vor 20 Stunden
Munich, Deutschland Vantis Vollzeit**THE ROLE**: Als Clinical Research Associate (M/F/d) unterstützt du die Untersuchung der klinischen Wirksamkeit unserer innovativen digitalen Medizinprodukte maßgeblich. Dabei arbeitest Du eng mit unseren Prüfzentren, unserem Clinical Team sowie externen Dienstleistern zusammen. - Begleite und überwache die operative Durchführung von klinischen Studien...
-
Senior Clinical Research Associate
vor 7 Monaten
Munich, Deutschland Proclinical VollzeitProclinical Staffing are partnered with an established CRO currently looking for an individual to join their team. This role is on a permanent basis located in Germany. The opening position is for an Experienced Clinical Research Associate. **Responsibilities**: - Work alongside and mediate with study team members for project implementation assistance when...
-
Experienced Cra
vor 7 Monaten
Munich, Deutschland Meet Recruitment Vollzeit60000 EUR - 70000 EUR - Munich, Germany - Permanent **Clinical Research Associates II bis Senior CRA (m/w/d) - Sponsor Dedicated Team bei einem Top 10 CRO** Unser Kunde, eine der renommiertesten Clinical Research Organizations (CROs) weltweit, sucht erfahrene und motivierte Clinical Research Associates (CRA II bis Senior CRA), um das Sponsor Dedicated Team...
-
Sr Cra
vor 21 Stunden
Munich, Deutschland Hobson Prior VollzeitHobson Prior are seeking for a SR CRA to join a brilliant CRO on a permanent basis located anywhere in Germany with the ability to travel within the DACH region. Our client is focused on personalised and scalable solutions. Please note that to be considered for this role you must have the right to work in this location. **Key Responsibilities**: - For...
-
Clinical Research Associate
vor 6 Monaten
Munich, Deutschland Alira Health VollzeitJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...
-
Sr Clinical Trial Assistant
vor 1 Tag
Munich, Deutschland Labcorp VollzeitOur FSPx department is looking for a Sr. CTA or SU Associate profile to join and support their team and be dedicated to one of our client. As such, you will be an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. Main responsibilities: 1) Support with ICF design and implementation 2) Prepare and...
-
Clinical Research Associate
Vor 3 Tagen
Munich, Deutschland GKM Gesellschaft für Therapieforschung VollzeitTHINK BEYOND! - CHOOSE PASSION! - AND IMPROVE YOUR QUALITY OF LIFE. UNSERE PHILOSOPHIE Als moderne CRO schreibt GKM fachliche Kompetenz, Erfahrung, Flexibilität und Kreativität im Arbeitsalltag groß. Durch die Wahrung des Dienstleistungscharakters gegenüber seinen Kunden zeichnet sich das Unternehmen seit vielen Jahren durch Kontinuität und stetiges...
-
Clinical Research Associate
Vor 3 Tagen
Munich, Deutschland GKM Gesellschaft für Therapieforschung mbH VollzeitTHINK BEYOND! CHOOSE PASSION! AND IMPROVE YOUR QUALITY OF LIFE. UNSERE PHILOSOPHIE Als moderne CRO schreibt GKM fachliche Kompetenz, Erfahrung, Flexibilität und Kreativität im Arbeitsalltag groß. Durch die Wahrung des Dienstleistungscharakters gegenüber seinen Kunden zeichnet sich das Unternehmen seit vielen Jahren durch Kontinuität und stetiges...
-
Clinical Research Associate Specialist
vor 1 Monat
Munich, Bayern, Deutschland Allucent Vollzeit**Job Title:** Clinical Research Associate SpecialistAbout AllucentWe are dedicated to assisting small-medium biopharmaceutical companies in navigating the complex world of clinical trials, enabling them to bring life-changing therapies to patients worldwide.Role OverviewThis Clinical Research Associate (CRA) role involves working independently and...
-
Lead Clinical Research Associate
vor 7 Monaten
Munich, Deutschland Oracle VollzeitLead Clinical Research Associate (M/F/d)-230005GR **Applicants are required to read, write, and speak the following languages***: English **Preferred Qualifications** Oracle Life Sciences is a leader in cloud technology, pharmaceutical research, and consulting, trusted globally by professionals in both large and emerging companies engaged in clinical...
-
Experienced Clinical Research Associate
vor 7 Monaten
Munich, Deutschland Medpace, Inc. VollzeitJob Summary: **Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach.** **We...
-
Senior / Clinical Research Associate - Germany
vor 7 Monaten
Munich, Deutschland Thermo Fisher Scientific Vollzeit**Senior/CRA - Germany (Remote)** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while...
-
Senior Clinical Research Associate
vor 7 Monaten
Munich, Deutschland Thermo Fisher Scientific Vollzeit**Senior CRA - Germany** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking...
-
Junior Clinical Research Associate
vor 21 Stunden
Munich, Deutschland MSD Vollzeit**Job Description**: Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. In support of our existing team we are currently...
-
Clinical Research Associate
vor 7 Monaten
Munich, Deutschland Oracle VollzeitClinical Research Associate (M/F/d)-230005GQ **Applicants are required to read, write, and speak the following languages***: English **Preferred Qualifications** Oracle Life Sciences is a leader in cloud technology, pharmaceutical research, and consulting, trusted globally by professionals in both large and emerging companies engaged in clinical research...
