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Clinical Study Coordinator

Elypta is a Swedish molecular diagnostics company focused on reducing cancer mortality through early detection. Elypta is pioneering a metabolism-based liquid biopsy and measures the GAGome – system biomarkers of tumor metabolism. We are looking for a Clinical Study Coordinator to join the team and support the clinical development of Elypta.

BACKGROUND

Elypta discovered that the comprehensive profile of blood and urine glycosaminoglycans – the GAGome – are accurate system biomarkers of tumour metabolism. Clinical studies to date have shown their exceptional potential for early cancer detection, which is key to improving patients’ survival. Elypta aims to be the first company to ever market an invitro diagnostic (IVD) test comprising of a kit to measure GAGomes as metabolic biomarkers of cancer, and software to interpret the measurements and return a test result. We are currently sponsoring the largest study ever in kidney cancer diagnostics as well as other IVD studies in other indications in oncology.

Elypta is now seeking a Clinical Study Coordinator who will be instrumental to support the clinical studies and clinical development in our company.

This is a full-time position in Stockholm, Sweden, at the Elypta headquarters in Solna, Karolinska Institute campus.


SUPERVISOR/MANAGER

The candidate will report to the Director of Clinical Development (DCD).

 

KEY RESPONSIBILITIES

The Clinical Study Coordinator (CSC) is a clinical study professional responsible for working with and under the direction of the DCD with tasks related to the conduct clinical studies. While the DCD is primarily responsible for overseeing and directing the studies, the CSC assists in the coordination and administration of the multiple study activities, from start-up to close out. By performing these duties, the CSC works internally with the DCD and the Clinical Development team, and externally with subcontractors and study Site/hospital staff, to support the management of the clinical studies.

General:

- Study Management: supports the DCD in organizing the day-to-day activities of multiple studies including problem solving, communication and protocol execution; assists in the development and/or maintenance of materials and tools necessary to appropriately manage and track the conduct and progress of the studies internally and externally, from start-up to closeout.

- Communication: assists with and/or communicates  study requirements, progress updates, practical arrangements and other study related issues internally, with study Site/hospital staff and subcontractors; attends and contributes to study-related internal and external meetings.

- Documentation: prepares and/or maintains study materials, establishes and organizes study files; prepares any modifications to the study documentation; contributes to the production and maintenance of study documents, ensuring template and version compliance.

Study Start-up:

- Contributes to the preparation of the study plan, study timelines and deadlines

- Supports the selection, qualification, training of study sites/hospitals

- Assists in timely submission of application/documents to EC/IRB and, where appropriate to Regulatory Authorities

- Supports in managing study contracts and/or grant/award terms and conditions; prepares and/or supports contract preparation with study Site/hospital staff and subcontractors.

- Assists in setting a categorized budget per study

Study Execution:

- Fosters the site recruitment process; provides feedback about recruitment progress, sample collection, data collection and resolution of queries

- Where needed, serves as main contact for communication with external study Site/hospital staff and subcontractors

- Executes the categorized budget per study; assists in maintaining accuracy and completeness of budgeted costs; confirms invoice requests received from subcontractors; confirms and follows-up on invoices received; where needed, confirms completion of data for payment; issues invoice request to sites; confirms and follows-up on invoices received

- Maintains and tracks stocks in-house, tracks expiry dates of consumables at sites, manages communication requests for re-supplies, prepares and ships consumables re-supplies

- Liaises with study site/hospital staff and/or courier to confirm date of samples receipt/shipment; receive, confirm and assist in inventorying samples and making them available for testing internally and/or externally

- Prepares, contributes to and distributes presentation material for meetings, and newsletters.

- Assists where needed in coordination of data collection, cleaning and validation

- Confirms and assists in inventorying samples and making them available for testing internally and/or externally

 

Study Close-out:

- Coordinates or supports coordinating the closure of all study Site/hospitals

- Supports the study team to ensure appropriate archiving of all essential documents

As Elypta advances, we expect the role and challenges we face to evolve, and we are therefore looking for a flexible candidate with a strong drive and motivation for development and who looks forward to supporting the clinical development and translation efforts needed to successfully bring a new diagnostic test to market and improve cancer patient outcomes.

 

REQUIRED QUALIFICATIONS

- BS or MS degree or equivalent in life science or healthcare

- Minimum of 1-2years of relevant work experience, e.g., clinical research studies, biobanking or laboratory testing in a Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) environment.

 

PERSONAL CHARACTERISTICS & SKILLS

- Good organizational skills, ability to manage multiple tasks, meticulous attention to detail and accuracy in work  

- Good written and oral communication skills, including good written and spoken English

- Humbleness and open-mindedness towards different perspectives

- Ability to complete assigned actions with high quality on a timely manner

- Ability to work independently as well as cross-functional and know when to seek help

- Mindful about the needs of the team and of all stakeholders in Elypta, in particular the patients our tests seek to help

- Creativity and ambitiousness to improve or create new products driven by new scientific discoveries made within or outside Elypta

- Computer literacy: e.g., Microsoft Word, Excel, PowerPoint, Outlook

- Good interpersonal skills; ability to articulate issues

- Ability to maintain confidentiality

- Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

Apply

INTERESTED?

Apply by sending a CV and cover letter to Eleanor Doolin, Charlton Morris: eleanor.doolin@lifesci-cm.com

Employment starts at earliest possible date.

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