Clinical Research Assistant

vor 7 Monaten

Wiesbaden, Deutschland Velocity Clinical Research, Inc. Vollzeit

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 Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities.

**Responsibilities**:
**Role & Responsibilities**:

- Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity’s SOPs
- Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
- With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations
- Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
- Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial
- Enter source data into the sponsor's and/or vendor’s data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator
- Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator
- Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial
- Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information
- Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team
- Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed
- Prepare source document charts, copy and/or file medical records and study related documents as required.
- Other duties as assigned

Qualifications:
**Education/Experience**:

- High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences 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 to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
- Understanding of verbal, written, and organizational skills
- Demonstrated ability to work as a team player
- Demonstrated ability to read, write, and speak English
- Demonstrated ability to multi-task
- Demonstrated ability to follow written guidelines
- Demonstrated ability to be flexible/adapt as daily schedule may change rapidly

**Required Physical Abilities**:

- Sit or stand for long periods of time
- Communicate in person and by a telephone
- Limited walking required
- Limited to lifting up to 30 pounds

Velocity is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. We are an E-Verify Employer in the United States.

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