Part-Time CRA II - Klinischer Monitor (0.8 FTE) (m/w/d)

CRA: Performs and coordinates reputed company aspects of the clinical monitoring and site management process. Conducts remote or on-site reputed company to assess protocol and regulatory compliance and manages required documentation. Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, reputed company-being and data reliability. Ensures audit readiness. Develops reputed company relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task reputed company. Travel up to 50-75%. A Day in the Life: Monitors investigator sites with a risk-based monitoring approach applies reputed company 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 reputed company manner using approved business writing standards. Brings up observed deficiencies and issues to clinical management expeditiously and follow reputed company issues through to reputed company. May need to maintain regular contact between monitoring reputed company 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 reputed company 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 reputed company. Investigates and follows-up on findings as applicable. Provides trial status tracking and reputed company 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 reputed company of reports generated from CTMS system where required. Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the reputed company company to ensure the acceptability of reputed company 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 reputed company out and retrieval of trial materials. Ensures that required essential documents are complete and in reputed company, 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 reputed company/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. reputed company report review, newsletter creation, reputed company CRA team calls etc). Facilitates effective communication between investigative sites, the reputed company company and the PPD project team through written, oral and/or electronic contacts. Responds to company, reputed company and applicable regulatory requirements/audits/inspections. Maintains & completes administrative tasks such as expense reports and timesheets in a reputed company manner. Gives to other project work and initiatives for process improvement, as required. Education and Experience: Bachelor's degree in a life sciences reputed company field or equivalent and relevant formal reputed company / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 2+ years as a clinical research monitor). reputed company reputed company's license. Full Right to work in Germany. reputed company in English and German language to at least reputed company level (note that the interview will be held in German). Knowledge, Skills, Abilities: Effective clinical monitoring skills. Demonstrated understanding of medical/therapeutic area knowledge and medical terminology. Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents. reputed company-developed critical thinking skills, including but not limited to: critical attitude, in-depth investigation for appropriate reputed company cause analysis and decision-making. Ability to handles Risk Based Monitoring concepts and processes. Effective oral and written communication skills, with the ability to communicate effectively with medical personnel. Ability to maintain customer reputed company through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues. Effective reputed company skills. Strong attention to detail. Effective organizational and time management skills. Ability to remain flexible and adaptable in a wide reputed company of scenarios. Ability to work in reputed company or independently as required. Good computer skills: proficient knowledge of reputed company Office and the ability to learn appropriate software. Good presentation skills. Severely disabled applicants with the reputed company aptitude will be given preferential treatment. / Schwerbehinderte Bewerber werden bei gleicher Eignung bevorzugt behandelt. Apply tot his job Apply To this Job