Aktuelle Jobs im Zusammenhang mit Clinical Services Support Associate, Germany - Munich, Bayern - WCG Clinical
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Clinical Services Engagement Associate, Germany
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Clinical Services Engagement Associate, Germany
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Clinical Services Associate
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Clinical Services Engagement Associate
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Clinical Research Associate
vor 1 Monat
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Clinical Services Support Associate, Germany
vor 3 Monaten
JOB SUMMARY:
The Clinical Engagement Specialist plays a crucial role in facilitating communication and activities between clinical research sites and internal teams to prepare for and execute clinical evaluations in line with project-specific requirements. The ideal candidate delivers exceptional customer service and ensures that assessment-related tasks are conducted and completed punctually, meeting client expectations.EDUCATION REQUIREMENTS:
A Bachelor's Degree in healthcare, life sciences, or a related discipline, or equivalent professional experience in the pharmaceutical or biotechnology sectors.QUALIFICATIONS/EXPERIENCE:
- A minimum of 2 years of experience in clinical research trials or a related field.
- Experience collaborating directly with sponsors and research sites, demonstrating a successful track record in managing clinical assessment projects is preferred.
- Familiarity with psychiatric indications (e.g., depression, anxiety) is advantageous.
- Basic understanding of the clinical trial process, Good Clinical Practices (GCP), FDA regulations, and relevant clinical terminology is essential.
- Knowledge of Institutional Review Board (IRB) regulations is a plus.
- Proficient in office management software, capable of managing databases, generating reports, and analyzing data.
- Experience with electronic Clinical Outcome Assessment (eCOA) platforms is beneficial.
- Technical aptitude to troubleshoot hardware, software, and network issues.
- Ability to work independently and collaboratively in a dynamic environment while managing multiple projects simultaneously.
- Strong organizational, prioritization, and time management skills.
- Excellent communication and problem-solving abilities.
ESSENTIAL DUTIES/RESPONSIBILITIES:
To excel in this role, the individual must effectively carry out each essential duty and responsibility. The following requirements represent the knowledge, skills, and abilities necessary:- Collaborate with external clients, such as clinical research sites, and internal teams, including clinical science and clinician services, to deliver services as outlined in the project scope related to clinical assessments.
- Ensure adherence to company standards and expectations in Clinician Services, as measured by visit availability, wait times, clinician utilization, and compliance with safety reporting.
- Manage multiple clinical trials concurrently, ensuring assessments are scheduled, initiated, and completed in accordance with study protocols.
- Provide administrative support for studies, including data entry, report generation, and database management.
- Foster and maintain positive relationships with study participants, healthcare professionals, and other stakeholders. Offer basic technical support for hardware, software, and network issues to sites as needed.
- Develop project-specific manuals for the Assessment Solutions team as required by the study scope of work.
- Independently identify, resolve, and escalate issues to the appropriate internal team members.
- Assist in onboarding new clinical research sites by facilitating site training, equipment testing, and mock assessments.
- Monitor query notifications and resolution processes with sites to ensure data integrity.
- Track subject visits and ensure compliance with risk reporting processes through report monitoring.
- Review protocols to support custom report generation for monitoring and tracking data captured in the clinical eCOA system.
- Develop and implement strategies to mitigate risks that could lead to deviations from study protocols.
- Alert Investigators/Sites, Clients, and the Clinical Science team when patient risks are reported, ensuring acknowledgment from both the Investigator/Site and Client.
- Assist in the development of site-facing IR documents and internal project plans specific to the Assessment Solutions services as detailed in the project scope.
- Perform other duties as assigned by the supervisor, which may occasionally be unrelated to the position described.
- Attendance and punctuality are essential functions of this role.
TRAVEL REQUIREMENTS: Up to 5% based on business needs.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to perform sedentary work, which includes sitting for extended periods and occasionally lifting up to 25 lbs (11.3 kg). Further guidance on physical activities, requirements, visual acuity, and working conditions is available in HCM.
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