Clinical Research Coordinator I - Leipzig, Deutschland - Velocity Clinical Research, Inc.

Velocity Clinical Research, Inc.

Geprüftes Unternehmen

Leipzig, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Overview:

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites.

At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise:
to bring innovative medical treatments to patients.

We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

Summary:

The Clinical Research Coodinator I conducts and manages clinical trials in accordance with the study protocol,GCP, and Velocity's SOPs.

Responsibilities:

Duties/Responsibilities:

Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity's SOPs
Implement research and administrative strategies to successfully manage assigned protocols.
Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information
Ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and Velocity SOPs.
Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
Ensure staff are delegated and trained appropriately and documented
Create, collect, and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.
Execute recruitment strategies defined by Clinical Research Team
Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
Perform clinical duties (e.g. drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
Promote respect for cultural diversity and conventions with all individuals.

Qualifications:

Education/Experience:

Bachelor's degree with 1 year of relevant experience in the life science industry OR
Associate's degree with 2 years of relevant experience in the life science industry OR
High School Graduate and/or technical degre with minimum of 3 years relevant experience in the

life science industry

Required Licenses/Certifications:

Phlebotomy if applicable and required by state law
Intramuscular dose administration and preparation if applicable and required by state law

Required Skills:

Demonstrated knowledge of medical terminology
Demonstrated ability in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multiline telephone.
Demonstrated bility to work in a fastpaced environment
Demonstrated verbal, written, and organizational skills
Demonstrated interpersonal and communication skills
Demonstrated ability to work as a team player
Demonstrated ability to read, write, and speak English
Demonstrated ability to multitask
Demonstrated ability to follow written guidelines
Demonstrated ability to work independently, plan and prioritize with some guidance
Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
Must be detail oriented
Demonstrated problem solving and strategic decision making ability.
Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised.