Role Purpose

The Clinical Research Associate 2 (CRA2) 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

• Coordinate the identification, feasibility assessment, and selection of investigators and

sites to undertake the trial.

• Complete all monitoring activities per the Monitoring Plan along with completing

monitoring visit reports, accurately and within the predetermined timeframe.

• Prepare, plan, organise, and conduct site evaluation visits and report on these visits to

assist in site selection.

• Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the

preparation of regulatory packages, importation/exportation requirements, and

updates of Ethics Committee packages.

• Negotiate site budgets, coordinate for site contract execution, track invoicing, and

ensure timely site payments.

• Prepare, plan, organise, and conduct site initiation visits.

• Develop and maintain appropriate monitoring tools and project-specific documents.

• Motivate and train investigators to ensure that the trial site personnel have a good

understanding of the protocol, investigational product, and requirements of the trial so

they can fulfill their obligations to conduct the trial accurately and to deadlines.

• 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 the trial including reporting of subject safety - adverse/serious

adverse events, protocol violations/deviations, and liaise with 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 escalate

as appropriate.

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

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

• Reconcile contents of in-house TMF and site’s Investigator Site Files.

• Coordinate distribution, tracking, handling, and destruction of investigational product

and other trial supplies per site/trial requirements.

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

tracking and reporting tools for the trial.

• Support strategies to boost recruitment efforts.

• Coordinate and perform translation verification of regional language, as required or as

applicable per region.

• Perform project site close-out visits and other site activities including archiving, as

applicable.

• Mentor, coach, and train junior staff members as directed by line management.

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

Lead.

General
• Maintain up-to-date and accurate timesheet records.
• Utilise all designated systems relevant to this role.
• Submit expenses within expected timeframes.
• Demonstrate understanding and adherence to Emerald Clinical’s values.
Personal Development
• Participate in setting objectives, performance improvement activities, and
implementation of career development plans.
• The CRA2 position is for those wishing to become a Senior CRA (SCRA) by following
the CRA2 to SCRA development pathway.
Training, Quality and Compliance
• Complete mandatory training for this role within specified timelines.
• Identify resources and training to support learning and development within this role.
• Ensure quality control of all relevant processes and activities performed.
• Report and escalate identified risks and issues in areas of responsibility according to
Emerald Clinical and/or project requirements.
• Comply with all applicable regulations, guidelines, SOPs, and project-specific
requirements.
Customer Focus and Teamwork
• Manage effective communication with key stakeholders, e.g., Investigators, site staff,
vendors, internal teams, etc.
• Attend and actively participate in Emerald Clinical meetings, activities, and other
internal meetings as required.
• Provide input to systems, tools, and processes to support continuous improvement.
• Share knowledge with others to facilitate learning and development across the
organisation.
• Maintain professionalism and accountability in all business activities conducted,
especially when managing external stakeholders.
Work Health and Safety
• Comply with Work Health & Safety (WH&S) legislation and operate in accordance with
established organisational WH&S practices and procedures.
• Promote and contribute to a safe, secure environment for staff and visitor

Education and Experience
• Tertiary qualifications in a related science or health care discipline

• Previous experience in clinical trials within an academic, CRO, or pharmaceutical
environment

Competencies
• Display competence in the following technical areas: ethical and participant safety
considerations, site start-up management, site conduct management, risk
management, quality management, supply management, scientific concepts and
clinical research design, and issue escalation management.
• Demonstrate competence in the following business skill areas: negotiation and
conflict resolution, critical thinking, problem-solving, decision making, and strategic
thinking.
• Demonstrate solid interpersonal communication, presentation skills, and flexibility to
work well within a multi-disciplinary team both autonomously and with a wide range of
varying stakeholders.
• Possess organisational and time management skills, which include the ability to
organise and prioritize, take initiative, and follow up independently to ensure
deliverables are met on time.
• Demonstrate practical knowledge of ICH-GCP guidelines and global and local ethical
and regulatory research requirements.
• Possess an understanding of medical terminology and physiology.
• 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.