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ROLE INTRODUCTION

Role Name / Title

Senior Clinical Research Associate

Reporting To

Clinical Research Associate Line Manager

Grade/ Level Junior Level

Function

Clinical Operations

Location

Greece

KEY RESPONSIBILITIES KPIS OF THE ROLE

These responsibilities are representative, and the role holder is also responsible for any other job assigned by the superior authorities from time to time. This section in not intended to be an exhaustive listing of all activities done by the role holder. It should capture only the key responsibilities of the role.

Responsibilities

Site Evaluation and Selection

• Conduct pre-study visits at potential investigational sites to perform feasibility assessment.

• Design feasibility evaluation questionnaire in collaboration with Clinical Research Associate (CRA) Manager and collect relevant information from investigators.

• Verify and validate the qualifications and capabilities of the investigator site to ensure compliance with study requirements.

Site Preparation and Monitoring

• Work closely with the Regulatory Affairs department and Clinical Operations staff to prepare study contracts, manage hospital IEC study submissions and approval.

• Describe the objectives, setup, procedures of the clinical trial and train investigators in the conduct of clinical trials, in compliance with study protocol.

• Conduct remote/onsite monitoring visits as per the study plan to ensure compliance with clinical protocols and ICH GCP guidelines.

• Achieve adequate supply of study medication for the site, verify drug accountability process, and ensure the safe shipment, storage, dispensing, return, and destruction of study drugs as required.

• Collaborate with study/Quality Assurance team to ensure that corrective actions are implemented and achieve site readiness in the event of an audit/regulatory inspection.

• Achieve sponsor satisfaction through closing their queries and escalating to achieve timely resolution.

Site Data Management and Reporting

• Verify that investigator qualifications and resources remain adequate throughout the trial period and review data reported in the electronic Case Report Form (eCRF) against source data.

• Coordinate timely safety reporting to the sponsor, train investigators on AEs/SAEs reporting, and confirm prompt submissions to IEC/IRB or regulatory authorities.

• Prepare and send follow-up reports summarizing discussions and actions from monitoring visits or contacts to investigators.

• Monitor data collection processes to ensure accuracy compliance with study protocols and escalation as per matrix for deviations.

• Act as the CRA Manager designee for specific activities and country point of contact for vendors involved in operational aspects for an assigned study (e.g., CROs), and participate or lead global/local task forces and initiatives

as and when required

Patient Recruitment and Safety

• Discuss recruitment strategies and timelines with investigators ensuring procedures align with the operational plan and target patient criteria.

• Obtain and verify written informed consent from all subjects, ensuring compliance with ICH GCP guidelines and legislation.

• Monitor patient safety by checking lab reports, ensuring proper dispensing of study drug to the patient.

Site Closure

• Execute relevant activities to close the study site upon completion of the clinical trial.

• Conduct a final review of data integrity and facilitate the return or disposal of any remaining study supplies in accordance with regulatory requirements.

• Archive all relevant study documentation to ensure compliance with regulatory standards and future audit requirements.

• Aid with financial matters at investigator sites, including timely processing and management of investigator payments and budget monitoring.

Policies, Processes and Procedures

• Assist in formulation of policies, processes and procedure and ensure day- to-day execution in line with function standards regulations.

• Provide inputs for improvements in business processes, specifications and best practices.

• Provide coaching, mentoring and management to the newly appointed and/or inexperienced CRAs to ensure that their role and contribution is optimized

• Achieve compliance with the company’s Quality and Information Security Management Systems, ICH GCP guidelines, applicable local and international legislation, including data protection legislations.

OPERATING NETWORK

This will include both internal (excluding sub-ordinates) and external stakeholders.

Internal

Data Management team, Pharmacovigilance Team, Clinical Supplies Team, Regulatory Team

External

Investigator sites, Regulatory Authorities, Vendors

ROLE PROFILE REQUIREMENTS

Education

Bachelor’s degree in life or health related field

Experience

3 to 5 years of experience as a Clinical Research Associate; Exposure of handling trials for global clients preferred

Functional / Behavioral Skills required to execute the role

TECHNICAL / FUNCTIONAL COMPETENCIES

BEHAVIORAL COMPETENCIES

• Clinical trial processes
• ICH GCP guidelines, and applicable local and international regulation

• Data Management

• Project Management
• Financial acumen

• Detail orientation
• Communication
• Problem Solving
• Collaboration

CAREER MOVEMENTS

Feeder Role(s)

Clinical Research Associate

Next Role(s)

Clinical Research Associate Line Manager

Job Title:

Clinical Trial Physician

Department:

Clinical Science Department

Reports to:

Associate Director, Clinical Science

Position Summary

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization.

Main Duties Responsibilities

• Is responsible for the development of:

• All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.),

• Scientific presentations and manuscripts,

• Medical training material (i.e. therapeutic area and study protocol training material)

• Delivers internal and external study protocol and therapeutic area training courses

• Provides medical expertise and consultation within the Company on key therapeutic areas of the clinical development program

• Provides guidance to all involved departments on the medical and scientific aspects of the assigned clinical trials/projects.

• Responds to medical queries from all involved parties in assigned clinical trials (e.g., CRAs, Project Managers, Clinical Operations Managers, Investigators) and collaborates with all concerned staff in maintaining an up-to-date study-specific QA log

• Is available 24/7 to respond to urgent medical/protocol related issues derived from an Investigational Site, as applicable

• Performs periodic medical review of the data from clinical trials according to the study- specific Medical Review Plan requirements (e.g., review of eligibility, review of efficacy

and safety data).

• Performs real-time medical review on urgent medical and safety issues, as needed
• Collaborates with and provides medical input to the Data Management staff to ensure the successful development of the study-specific eCRF

• Attends Investigator Meetings and Conferences, as applicable

• Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection and ICH GCP requirements

Education Requirements

• Required: Medical Degree

• Preferred: MSc or PhD or Acquired Specialization

(Clinical, Medical Information, Medical Affairs or PV)

Language Skills Required

• Exceptional written and oral use of English

Key competencies

• In-depth knowledge of medical and drug terminology
• Good medical judgement and ability to make medical decisions
• Excellent communication skills
• Excellent business acumen
• Initiative taking and team working attitude
• Excellent Organizational skills
• Innovative thinking
• Excellent IT skills
• Deep understanding of the Clinical Development industry

Job Title

Name of Employee/Line Manager

Signature

Date

Clinical Trial Physician

Associate Director, Clinical Science

Functional Role

Clinical Investigator/ Clinical Research Physician

Department

CRD

Reporting to

Location

Primary Responsibility

Description

Protocol, Informed Consent Form (ICF), Case Report Form (CRF) preparation

• To coordinate with clinical research personnel for preparation of Protocol.

• To coordinate with clinical research personnel for preparation of ICF and CRF.

Ethics submission

• To coordinate with Investigator for submitting the study related documents (clinical updates) to Independent Ethics Committee.

Study

• To coordinate with investigator for planning of study schedule.
• To coordinate with screening team for subject recruitment and screening.

• To ensure that all volunteers reported for ICF presentation are fit for participation in the study as per respective protocol.

• ICF presentation at the time of participation of subjects in a particular study.

• To conduct clinical examination and monitor vitals for well-being of subjects during the study.

• To ensure safety and well-being of study subjects.

• To handle and report adverse events and drug reactions and clinical emergencies in co-ordination with investigator.

• To take clinical decisions in absence of investigator and take opinion of investigator as and when required.

• To guide nursing staff for maintenance of emergency medicines and Special Care Room.

• To provide medical help to employees as well as subjects.

• To monitor studies and ensure that studies are conducted as per approved Protocol, International Conference on Harmonization-Good Clinical Practice (ICH-GCP), and in house Standard Operating Procedures (SOP).

• To coordinate with clinical staff for admission, discharge, meal distribution, dosing / dosing supervision and monitoring subjects during studies for restriction compliance.

• To generate and maintain essential documents pertaining to studies.

Report preparation

• To list out protocol / SOP deviations related to clinical examination and vital measurements, and incorporate the same in final report in consultation with investigator.

Feasibility assessment

• Coordinate with clinical research personnel for feasibility assessment of various molecules.

Others

• Any other task assigned by reporting authority.

Prepared by (Reporting Manager)

Reviewed by (Department Head)

Name

Designation

Signature Date

Functional Role

Clinical Investigator/ Clinical Research Physician

Department

CRD

Reporting to

Location

Primary Responsibility

Description

Protocol, Informed Consent Form (ICF), Case Report Form (CRF) preparation

• To coordinate with clinical research personnel for preparation of Protocol.

• To coordinate with clinical research personnel for preparation of ICF and CRF.

Ethics submission

• To coordinate with Investigator for submitting the study related documents (clinical updates) to Independent Ethics Committee.

Study

• To coordinate with investigator for planning of study schedule.
• To coordinate with screening team for subject recruitment and screening.

• To ensure that all volunteers reported for ICF presentation are fit for participation in the study as per respective protocol.

• ICF presentation at the time of participation of subjects in a particular study.

• To conduct clinical examination and monitor vitals for well-being of subjects during the study.

• To ensure safety and well-being of study subjects.

• To handle and report adverse events and drug reactions and clinical emergencies in co-ordination with investigator.

• To take clinical decisions in absence of investigator and take opinion of investigator as and when required.

• To guide nursing staff for maintenance of emergency medicines and Special Care Room.

• To provide medical help to employees as well as subjects.

• To monitor studies and ensure that studies are conducted as per approved Protocol, International Conference on Harmonization-Good Clinical Practice (ICH-GCP), and in house Standard Operating Procedures (SOP).

• To coordinate with clinical staff for admission, discharge, meal distribution, dosing / dosing supervision and monitoring subjects during studies for restriction compliance.

• To generate and maintain essential documents pertaining to studies.

Report preparation

• To list out protocol / SOP deviations related to clinical examination and vital measurements, and incorporate the same in final report in consultation with investigator.

Feasibility assessment

• Coordinate with clinical research personnel for feasibility assessment of various molecules.

Others

• Any other task assigned by reporting authority.

Prepared by (Reporting Manager)

Reviewed by (Department Head)

Name

Designation

Signature Date

Functional Role

CRA/Sr. CRA

Department

COD

Reporting to

Location

Primary Responsibility

Description

Off-site Monitoring

• To undertake off-site visits during different phases of study period, As per study plan conduct Initial Site Visit to train and guide site personnel.

• To inspect pre-requisite as per protocol and ensure site is ready for the study, undertake routine monitoring visits at predetermined frequency as per study guideline.

Communication Documentation

• To communicate for Feasibility Assessment Questionnaire and fetch necessary detail for review from potential sites.

• To take follow-up on routine basis with off-site nodal/in-charge, prepare visit reports (Pre-study Qualification Report, Site Initiation Visit report, Site Monitoring Visit Report, Site Closeout Visit Report) as per frequency with Edit of study trials and submit for review.

• To procure pre-requisite documents (like calibration reports, agreements, etc) from sites and vendor at the time of study start up and during the study.

• To provide various data formats (Logs and form, Source data temples, recruitment trackers, Feasibility questionnaire etc.) to off-site team and ensure capturing/recording of data as per same.

Audits Compliance

• To review study related documents generated during the study in accordance with various SoPs/Protocol/Regulatory requirements.

• To train/guide/mentor off-site team on study protocol/Regulatory aspects (GCP, Root Cause Analysis, updated regulatory requirements etc.) periodically.

• To respond/comply to queries raised by internal (QA/QC) and external (Sponsor/Regulatory) auditors.

• Any other task assigned by reporting authority.

Prepared by (Reporting Manager)

Reviewed by (Department Head)

Name

Designation

Signature Date