Sr CRA III FSP Germany

Work Schedule

Environmental Conditions

Job Description

Join Us as a Senior Clinical Research Associate (Level I) Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

What Youll Do:
Monitors investigator sites with a risk-based monitoring approach: applies rootcause analysis (RCA) critical thinking and problem-solving skills to identify siteprocesses failure and corrective/preventive actions to bring the site intocompliance and decrease risks. Ensures data accuracy through SDR SDV andCRF review as applicable through on-site and remote monitoring investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates 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.
Contributes 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.
Contributes to other project work and initiatives for process improvement as required.

Education and Experience Requirements:
Bachelors degree in a life science related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

• Total experience:at least 3 years as a CRA

• Cell therapy experience:at least 2 years of on-site hands-on experience

• Location:various locations

Knowledge Skills and 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
Well-developed critical thinking skills including but not limited to critical mindset in-depth investigation for appropriate root cause analysis and problem solving
Ability to manages 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 focus through the utilization of good listening skills attention to detailand the ability to perceive customers underlying issues
Effective interpersonal skills
Strong attention to detail
Effective organizational and time management skills
Ability to remain flexible and adaptable in a wide range of scenarios
Ability to work in a team or independently as required
Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
Good presentation skills