Clinical Research Associate 3

1. Education/Qualifications Required
Graduate, postgraduate, 4-year college degree or equivalent, ideally in a scientific or healthcare discipline.

2. Experience
Three (3) years or more as Clinical Research Associate (CRA) either in Clinical Research Organisation (CRO) or pharmaceutical industry.

3. Job Summary
Administration and full investigator site responsibility for clinical studies according to Standard Operating Procedures (SOPs), ICH-GCP and local regulations;
May assume line management responsibilities for CRAs;
Acts as mentor for less experienced CRAs;
May act as lead CRA assisting a Project Manager (PM);
May act as lead CRA or as a PM of national studies;
Ensures clinical trials are monitored such that subjects' rights, safety and well being are protected and that the clinical trial data are reliable.

4. Job Duties and Responsibilities
a. Clinical Trials
Acts as a member of the project team with the goal to contribute towards efficient management of trials;
Assists the PMs in the preparation and review of protocols and informed consent forms;
Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.);
Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;
Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks as instructed by the PM;

Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports;
Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports;
Performs pre study visits: discusses protocol, other available study documentation and study requirements with Investigator and other trial staff, ensures that trial staff and site facilities and the site's recruitment potential are in accordance with protocol requirements, local regulations, ICH-GCP and SOPs;
Performs initiation visits: trains Investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ICH-GCP and SOPs;
Performs monitoring visits: ensures adherence to protocol, accurate data collection via comprehensive source document verification, and investigational product/biological samples/supplies accountability;
Communicates effectively with site personnel, including the Principal Investigator (PI), and management to relay protocol/study deviations and ensure timely implementation of corrective actions;
Develops and maintains strong working relationship with Investigators and study staff, serving as an ambassador to promote a high quality and ethical image;
Maintains study tracking, in accordance with the demands of the study;
Understands and updates Clinical Trial Management System (CTMS) in a timely manner;
Monitors and updates data in an Electronic Data Capture (EDC) system (where used) in a timely manner and in accordance with study specific guidelines;
Performs data management review, including in-house CRF review, and alerts project managers and data managers to emerging issues with CRF completion;
Identifies and processes Serious Adverse Events (SAEs) according to the procedures defined by the study team;
Demonstrates a broad understanding of the SAE reporting process to regulatory authorities;
May write SAE narratives to support pharmacovigilance activities;
Liaises with data management to resolve data discrepancies and ensure all data management study goals are met;
Prepares and performs closeout visits according to the protocol, local laws, ICH-GCP and SOPs;
Prepares accurate and timely visit reports from all types of visits;
Functions as a mentor, assisting with the training and developing of less experienced CRAs via shadow or co-monitoring visits;
May be involved in preparation of status reports for clients;
Assists with review of clinical study reports;
Conducts feasibility work;
Assists in business development;

Interacts with internal work groups to evaluate needs, resources and timelines;
Initiates payment requests for Investigators;
Develops SOPs when required;
Assumes project management responsibility as needed;
Performs other duties as assigned by management;
Travels as necessary according to project needs.

b. Management of other CRAs

Management of Administrative Aspects
Responsibility for all of the following administrative aspects according to SOPs:
Ensures that each new CRA undergoes induction and that the induction was successful and productive;
Verifies that curriculum vitae (CV), job description and training records are complete and current for Human Resources (HR) files;
Reviews and authorises AREA (timesheets) and reviews monthly and weekly activities to assess the workload of CRAs;
Reviews and authorises CRA expense reports in accordance with company and project guidelines;
Validates travel and hotel requisition forms if delegated;
Ensures annual leave and sick leave are approved and taken in accordance with company guidelines.


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