Clinical trial accociate III

• The CRA III is the primary contact person of different stakeholders including but not limited to
• investigational site staff, study management team, subcontractors involved in studies.
• The CRA III participates in the implementation and monitoring of clinical studies ensuring
• quality and reliability of collected data in compliance with regulations and good clinical
• practices and according to timelines.
• The CRA III can act as a Team Lead on studies where a CPL is not appointed.

RESPONSIBILITIES & TASKS

• The CRA III reports to the CM/ RM. However, on the project level, reports to the Clinical

• Project Lead (CPL).

• Works in accordance with Quality Documents.

• Ensures the conduct of the study according to local regulations and protocol.

• Performs accompanied visits (pre-authorization and routine accompanied site visits) with more junior CRAs, whenever required.

• Performs feasibility, site selection visits and can take decisions about site participation with minimal support from CM and CPL.

• Collects regulatory and administrative documents needed for the constitution of the submission package and submits them to the corresponding Ethical Committees and

• Regulatory Authorities under the supervision of the CPL and CM/ RM.

• Conducts site initiation visits.

• Participates and/ or organizes international and/ or local investigators/ CRA meetings.

• Manages relationships with sites (investigators, nurses, laboratories, pharmacists etc.).

• Handles all logistical aspects of a clinical study.

• Ensure study monitoring

• Checks the quality of collected data, detects errors and deviations during clinical study and suggests corrective actions.

• Checks the consistency between data reported in CRF and source documents.

• Applies and enforces regulation and procedures in force throughout the study duration.

• Ensures SAE’s notification by investigator in respect to delays and handle follow-up with

• Sponsor in collaboration with CPL.

• Checks storage conditions, distribution, returns of Investigational Products (IPs).

• Ensures updating of study master file and investigator site file.

• Identifies, follows and resolves logistics issues.

• Provides the necessary support to the site study team (motivation and training).

• Updates and reports the collected information at site in a monitoring visit report or contact report form (according to MCT template or to the Sponsor template as appropriate).

• Summarizes relevant information to be reported to CPL.

• Assists the investigator in all requests and notifications.

• Keeps and files any exchanged letters or e-mail with the investigator.

• Participates to investigational site audits or system audits.

• Ensures close-out visits of investigational sites.

• Prepares files to be archived at site.

• Organizes return of study materials and IPs for destruction.

• A CRA III is authorized to train more junior CRAs during site visits and is required to complete the relevant Site Visit Training Report.

• Writes/ updates Quality Documents in case of being the process owner.

• Compared to CRA II, the CRA III is able to manage more complex studies requiring expertise in using study tools and good master of study manuals, can work in parallel on different accounts and different therapeutic areas.

• If provided with the responsibility to act as a Team Lead, the CRA III performs CPL tasks and

• reports to the AOM on the project progress. The above list of tasks and responsibilities is

• subject to reasonable changes, within the frame of the above mentioned mission.

• Check the below relevant boxes:

1. Acts as Team Lead

2. Acts as Training and Compliance Coordinator

3. Acts as Regulatory Officer

QUALIFICATIONS

• Minimum of 4 years’ experience in monitoring clinical trials and / or deemed fit for promotion by LM based on documented performance review with good performance indicators.
• Be trained on ICH- GCP and shows good understanding and ability to implement GCP principles.
• Able to train investigators and delegated site staff on all aspects of the studies and guide them to adhere to local and international quality standards.
• Has sufficient fluency in English and Armenian to be able to work in a context of international studies.
• Has a minimum of a Bachelor degree in Arts or Science.

COMPETENCIES

• Able to learn quickly and open to new learnings.
• Has strong interpersonal skills and able to manage high number of interlocuters.
• Is well organized and adhere to compliance concept.
• Very good management of priorities.
• Able to multi-task and achieve objectives in a timely manner.
• Has a logical and inquisitive mind.
• High Attention to details.
• Excellent numerical, written and verbal communication skills.
• Self-Confident.

For information please call- +374-41-773-701