Not provided by employer
SrClinical research associate (f/m/d)
Occlutech is a leading specialist provider of minimally invasive cardiac devices, with a mission
To improve the quality of life for people with heart conditionsThe vision is to become a global
Leading specialist provider in cardiac devices, addressing congenital heart defects, stroke
Prevention and heart failure.
Occlutech has a broad and proven portfolio, based on proprietary technology, and over 200
Patents with more than 139,000 products soldThe company markets and sells its products in
Circa 85 countries and has around 270 employees.
The senior clinical research associate ensures the overall quality of clinical trials by
Monitoring study data and managing site adherence to the protocol, gcp, all applicable
Regulations and related study documentsThe srCra is the primary contact with the study
Site and serves as the liaison between clinical investigators and the sponsor.
Your work will focus on
Independently performing site training, regulatory document collection, tracking
Enrollment, and ensuring case report forms are accurate, complete and verifiable
Against source documents.
Collaboration with field clinical specialist (fcs) to ensure site has all necessary
Procedure support during study enrollment period.
Contributing to the development and improvement of company procedures,
Processes, and templates.
Support of investigator qualification process by creating questionnaires and other
Assessment tools for use in the selection of sites.
Assistance in the development of site recruitment and retention strategy.
Assistance in the development of protocol / icf / crf / crf completion guidelines,
Preparation and maintenance of monitoring plans, study binders, study manuals, and
Other site specific and monitoring tools.
Requesting and collecting initial regulatory documentation.
Ensuring that sites fulfill their regulatory obligations and supports investigator-level
Irb submission efforts.
Submission of study-level documents for irb review and approval.
Tracking of essential study and site-level metrics and advising program manager
(pm) when an investigational site is approved and ready to receive investigational
Device supplies.
Planning and conducting training / site initiation, interim and close-out visits.
Completion of timely and accurate trip reports per specified windows in the monitoring
Plan.
Assessing and monitoring that investigational devices are available, used in
Accordance with labeling/ifu, handled correctly, stored, and accurately inventoried
And documented.
Following up with the site regarding timely completion of crfs and closure of data
Clarification forms/queries.
Assisting sites to resolve regulatory document issuesEnsuring adequate study and
Regulatory documentation is maintained at the both the investigator site and the
Sponsor etmf.
Verifying appropriate reporting and documentation of adverse events, device
Deficiencies, protocol deviations and enrollment metrics.
Documentation and report non-compliance in a timely mannerIdentification of areas
Requiring follow-up and improvement at each clinical site, recommend corrective
Action and or conduct site re-training as neededEnsures closure of open actions.
Communication of findings from monitoring visits to cpm in a timely manner.
Knowledge, skills and abilities (ksas)
Comprehensive knowledge of applicable clinical research regulatory requirements,
I.e., code of federal regulations (cfr), good clinical practice (gcp), international
Conference on harmonization (ich) guidelines, and iso 14155.
Proficiency in microsoft office applications.
Strong written and verbal communication skills
Good organizational, interpersonal and problem-solving skills.
Strong attention to detail.
Time management skills.
Ability to establish and maintain effective working relationships with coworkers,
Managers and clients and site personnel at assigned sites.
Experience with various edc, ctms, etmf systems.
Background experiences
Bachelor’s degree in a scientific field and 5 years of regulated, investigational trial
Monitoring experience; or equivalent combination of education, training, and
Experience.
Ide-pma (medical device) monitoring experience required.
Acrp or socra certification desired.
Working conditions:
In-house cra: this position exists in an office (and/or remote) environmentTravel up
Approximately 30%
Field cra: this is field based positionTravel of approximately 60% requiredOccasional
Weekend travel may be needed.
Are you interested?
We look forward to receiving your application (cover letter, cv, including qualifications and
References - all documents in one pdf file), your salary expectation and the earliest possible
Date for start of work to bewerbung@occlutech.com
Occlutech gmbh jena
Winzerlaer straße 2, 07745 jena, germany
Germany@occlutech.com, www.occlutech.com
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