Role Purpose

The Clinical Research Associate 1 (CRA1) is a member of the Clinical Operations group at

Emerald Clinical. The Clinical Operations group is responsible for site management,

monitoring tasks, and the operational support of clinical trials. The group allocates resources

to projects as appropriate to assist with implementing project plans and to ensure compliance

with regulatory requirements and Standard Operating Procedures (SOPs).

Key Accountabilities

In addition to the responsibilities outlined in the Clinical Trials Specialist (CTS) and/or Project

Assistant (PA) Position Description, the CRA1 will follow Emerald Clinical’s CTS/PA to CRA1

Development Pathway, along with the following accountabilities:

• Assist in the identification, feasibility assessment, and selection of investigators and

sites to undertake the trial.

• Learn to prepare, plan, organise, and conduct site evaluation visits and report on

these visits to assist in site selection.

• Assist in the preparation, submission, and/or liaise with regulatory specialist

colleagues, regarding the preparation of regulatory packages,

importation/exportation requirements, and updates of Ethics Committee

submission packages.

• Learn the process for negotiation of site budgets, site contract execution, invoice

tracking, and timely site payments.

• Learn to prepare, plan, organise, and conduct site initiation visits.

• Learn to develop appropriate monitoring tools and project-specific documents.

• Assist in motivating and training investigators to ensure that the trial site personnel

have a good understanding of the protocol, investigational product, and requirements

of the trial so that they can fulfil their obligations to conduct the trial accurately and to

deadlines.

• Learn to manage trial sites utilising both on-site and off-site activities including:

o Verification of quality, accuracy, completion, and timeliness of data.

o Ensure complete and efficient resolution of data queries, audits, issues, and liaise

with Data Management and/or Quality colleagues, as needed.

o Adhere to the trial protocol, all applicable project-related plans, as required by the

project training matrix, and other relevant project-specific requirements.

o Adhere to ICH/GCP and other regulatory guidelines and requirements as relevant

to this trial including reporting of patient safety, adverse/serious adverse events,

protocol violations/deviations, and liaising with EC safety colleagues as needed.

o Ensure targets, metrics, and quality are maintained per trial expectations.

o Identify risks associated with e.g., clinical trial design, privacy and confidentiality,

clinical trial misconduct, and take action to mitigate risk proactively and to escalate

as appropriate.

• Collect and review essential documents from trial sites, to ensure quality and

compliance, and code documents for the Trial Master File (TMF) filing.

• Assist in the reconciliation of contents of in-house TMF and site’s Investigator Site

Files.

• Assist with coordination of distribution, tracking, handling, and destruction of

investigational products and other trial supplies per site/project requirements.

• Maintain trial information using the clinical trial management system and any other

tracking and reporting tools for the trial.

• Learn how to help support strategies to boost recruitment efforts.

• Assist with project site close-out visit preparation and other site closure-related

activities including archiving, as applicable.

• Perform any additional responsibilities assigned by the Line Manager and/or Project

Lead

Education and Experience
• Tertiary qualifications in a related science or healthcare discipline.
• Exposure to medical terminology and physiology.
• Exposure to ICH/GCP, ethical and regulatory requirements.
Competencies
• Demonstrate solid interpersonal communication skills, presentation skills, and
flexibility to work well within a multi-disciplinary team both autonomously and with a
wide range of varying stakeholders.
• Possess excellent organisational and time management skills, which include the ability
to organise and manage priorities, take initiative, and follow up independently to
ensure deliverables are met on time.
• Demonstrate practical knowledge of ICH-GCP guidelines and global/local ethical and
regulatory research requirements.
• Proficient in navigating software/systems including Microsoft Office Suite along with
other project-specific management tools.
Additional requirements
• Ability and willingness to travel.
• Ability to be flexible and adaptable in the face of changing organisational priorities and
ambiguous environments.