Field Clinical Research Associate
Coordinate and conduct all activities required for setting up and monitoring a study, training and supporting the sites in their study activities for ensuring quality of their study conduct and compliance with the protocol, completing accurate study status reports and maintaining study documentation.
- Conduct Monitoring Visits (Site Feasibility Visit, Site Initiation Visit, Interim Monitoring Visit, site close-out Visit) including to monitor documents, status and proper study binders at the site. Handle and communicate immediate issues to the attention of the Impulse Dynamics Clinical Operations Manager Europe for timely resolution.
- Support and guide the hospital study nurse/coordinator in the collection and handling of all test data and test results in accordance with the study designs. Assure availability of source documents and recording of data in the study database by the site.
- Supervise and support the coordination of the patient follow up visits and tests at the different test sites/hospitals, where possible.
- Train, support, supervise and guide the hospital staff/study nurse/coordinator in the execution, collection and handling of all test data, CPET- tests/procedure in accordance with the study design.
- Work with the Impulse Dynamics Clinical Operations Manager Europe to ensure the success of CPET, and ensure that the relevant site personnel sends CPET and other tests results to interpretation by core laboratories.
- Support preparing of study related documents
- Support the data collection and review within the Clindex data base
- Home office (located around Frankfurt or Düsseldorf)
- Up to 80% travel required.
Skills and abilities
- Mobile, expected to actually be in the field, visiting sites (i.e. ability to travel, regional and beyond, approximately 80% of the time).
- Team player, compliant with international company communications, environment and policies
- Self-motivated and independent, well organized, takes responsibility and oriented to get the tasks done in a professional manner.
- Excellent communication (oral and written), interpersonal and organizational skills along with strong attention to details.
- Ability to multi task, prioritize workload, work under pressure, and meet deadlines.
- Strong analytical and problem solving/troubleshooting skills necessary.
- Strict attention to detail and strong organization skills necessary.
- Language skills: Fluent German and English (verbal and written professional communication)
- Routine work with computerized systems, data management and communications (including at the very least, excel files, email, etc., preferably also electronic databases such as Clindex/Fortress is an advantage)
Education and Experience Requirements
- Trained in Good Clinical Practice (GCP) with certification
- Field experience (preferably of more than 3 years) in activities related to communication with and submission of protocols to ethical committees and competent authorities, site initiation and training, assistance in data collection, monitoring study progress, documentation & CRFs, SAE reporting, and production of study related reports
- Experienced in medical device related clinical trials, including randomized controlled and registry studies
- Experienced in in-field conduct of FDA-related studies in Europe
- Experienced in in-hospital work environment, interaction with hospital staff and familiarity with typical hospital processes