Study Coordinator (Nurse/Data)

Study Coordinator (Nurse/Data)

Global Oncology Site Network

Discretionary Bonus Scheme

Travel (Approximately 60%) domestic and/or international

Introduction

At ICON, it's our people that set us apart.

Are you looking for an outstanding opportunity to develop your career with a leading edge Global Commercial Oncology Site Network which is growing fast?

Our Oncology Site Network concentrates on fast site set up, quick patient enrolment, high data and quality standards, delivering excellent patient experience resulting in a high level of patient retention. These qualities are what our Sponsors look for in a leading Oncology Site Network and you can be part of our success story. We are growing our international footprint and you can play a part in our expansion and be involved in the future of oncology treatments across the globe.

This is an excellent opportunity for a Study Coordinator with exposure to CROs, Research Sites and Networks to play an implemental role in driving our organisation towards success.

The Study Coordinator (Nurse/Data) is a specialised research professional, responsible for the coordination and administration of clinical trials under the direction of the Chief Medical Officer, Medical Director and the Principal Investigator. The Study Coordinator implements and coordinates research study procedures for the successful management of clinical trials. The Study Coordinator position requires someone who is knowledgeable of study specific protocols as well as regulations and guidance for the conduct of clinical trials.

Able to travel at a short notice both domestically and internationally (Approximately 60%).

Main Responsibilities

• Manage clinical research studies and adhere to Oncacare Standard Operating Procedures (SOPs), our healthcare partner's SOPs, Good Clinical Practices (GCPs), study protocols, clinical trial agreements, and regulations governing clinical research.

• Ensure scientific integrity of data and protect the rights, safety and well-being of research participants.

• Navigate the resources and workflow within the healthcare and clinical research environment to ensure seamless care for the clinical trial participant, to engage investigators in research daily and to promote clinical research within the healthcare system.

• Create and implement a patient engagement plan to identify and contact potential research participants, and then screen and enroll participants in suitable clinical research studies.

• Demonstrate competency with respect to both clinical trial conduct and specific research studies with investigators, healthcare partners, sponsor, CRO, research team, and potential and active research participants

• Coordinate research participant visits and study related procedures according to study protocol windows and study team schedules. This may involve handling travel logistics for research participants.

• Ensure reminder communications (phone, text or email as requested by the participant) are conducted to promote show rate and compliance

• Conduct clinical research study visits/procedures per protocol requirements.

• Dispense investigational product and other research study supplies in an accountable manner in accordance with study requirements, institutional requirements, investigator approval and regulations.

• Inform and educate the research team and healthcare system staff regarding study related procedures including IP dosing and monitoring requirements

• Assist with Integrating clinical research as a care option within the healthcare system

• Monitor and report adverse events, serious adverse events and protocol deviations to the investigator, sponsor and IRB in compliance with Oncacare's SOPs

• Know and understand regulatory requirements, maintain files and documents, and assist the Regulatory Navigator/Manager of Trial Activation with regulatory submissions.

• Create source documents and document appropriately in source documents and /or medical records (paper, EMR, e-source) per ALCOA: data is attributable, legible, contemporaneous, original and accurate.

• Complete and maintain case report forms (paper or electronic) and answer queries regarding study data per FDA regulations, clinical trial agreement and protocol requirements

• Prepare and participate in routine monitoring visits, internal and external audits, and inspections.

• Ensure study documentation is audit ready in the event of monitoring, audits and inspections.

• Assist with additional projects as requested by the Chief Medical Officer

Data Management

• Transcribing all data generated at site into electronic systems within the set timelines.

• Maintaining, filing and organising patient source notes and any associated data and files.

• Maintaining, filing and organising Investigator site files and associated documents.

• Ensure all folders are up to date, correctly labelled and stored securely and in an organised manner.

• Working to SOP/COPs and GCP guidelines

Query Resolution, data cleaning and Quality control

• Resolve queries generated by sponsor representatives and electronic systems within the set timelines.

• Liaise with relevant members of the clinical team to resolve queries and improve data quality.

• Maintain high quality standards by regularly checking data for any discrepancies.

• Provide review of source data worksheets during study start up.

• Assist operation compliance team in carrying out any data cleaning activities and internal audits.

• Ensure audit and inspection readiness and assist with preparation of audits and inspections.

• Ensure version control of all documents and liaise with QA team regularly

Coordinating CRA and other sponsor representative visits

• Book and coordinate CRA visits and phone calls to site for monitoring purposes.

• Address any findings during and after the visit and follow up letters within the set timelines.

• Ensure all files are inspection ready.

Administration

• As a team member at your site you are expected to work closely with Doctors/Nurses and other Site members under the supervision of the Principal Investigator to ensure the best outcome with regards to patient care and quality of service.

To be successful you will need:

• As a successful Study Coordinator, you will likely have:

• Registration with no limitations to practice as a nurse in your relevant jurisdiction.

• Ability to manage multiple research studies with no supervision.

• Awareness of research governance issues.

• An understanding of the research process.

• Well-developed interpersonal and communication skills.

• Clinical skills competency and laboratory processing competency.

• Motivated and enthusiastic.

• Ability to fulfil all aspects of the role.

• Post Graduate diploma in a health/biological sciences related area or equivalent is desirable but not essential.

• Management skills including experience of team leadership.

• Advanced organisational skills and time management skills.

• Ability to manage multiple projects at various stages of development.

• Knowledge of the application of research within the Clinical and Research Governance agenda.

• Excellent cross disciplinary/interagency communication skills and ability to facilitate collaborative working relationships.

• Possess a broad range of advanced Clinical skills and assessment techniques.

• Travel (Approximately 60%) domestic and/or international.

Why join us?

Ongoing development is vital to us, and as one of the Data Coordinators in our Global Oncology Site Network, you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment