Clinical Research Associate
- Communicate the progress and relevant information or escalate issues of the study to the appropriate study management team;
- Engage and maintain good written and verbal communication with external stakeholders in order to ensure effective study execution;
- Accountable for local activities required in set up and for high quality execution of studies; will seek managerial or other experienced support as appropriate:
• Performs operational site evaluation visits, study initiation visits, on and off site monitoring visits at the required frequency (Risk Based Monitoring) and site closeout visits;
• Performs site evaluation visits:
- Determines the feasibility of the study protocol with reference to study complexity
- Confirms staff availability, suitable clinical facilities, potential for per protocol patient population,
- Confirms ability to comply with ICH GCP and GSK requirements for clinical studies.
• Works with Local Study Manager (LSM) to carry out a local study / site level risk assessment;
• Assist (depending on local practices) the LSM with submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs) in cooperation with the Local Clinical Support Specialist (LCSS) and maintain communication with RA and ECs to ensure all regulatory requirements are met in timely manner throughout the study;
• Delivers appropriate training to site staff and other relevant parties, as required. Assists with web based and face to face GSK trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively run the clinical study;
• Participate in global investigators and/or monitor meetings as appropriate. Facilitates investigator's participation in global meetings and/or may assist the LSM with organizing local investigator meetings. Participates in other study meetings as required;
• Works with LSM/LCSS to facilitate the preparation of contracts and agreements with investigators, hospitals, pharmacies, labs, etc. using contract templates to run the studies in line with GSK's and regulatory requirements;
• Ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met;
• Maintain good relationships with site while communicating and implementing patient inclusion / exclusion criteria, study stop/go decisions, timeline changes, early termination of studies and changed status of studies;
• Ensure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP);
• Work with the sites to ensure they address data queries in a timely manner. Verifying that data entered in to the CRFs is consistent with patient medical notes;
• Ensure Investigator and site staff receives safety reports and new safety information in a timely manner;
• Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to GCSP and other relevant departments, within the required time frames;
• Completes monitoring visit reports within the agreed timelines;
• Works with LCSS to ensure local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track);
• Ensure all necessary study supplies (study drugs, other materials etc.) are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately;
• Ensure clinical study activities are conducted in accordance with the clinical trial agreement and related contracts;
• Ensure sponsor study records are inspection ready at all times and archives records as applicable;
• Assists with audits/inspections of study / sites in the country;
- Accountable for acquiring/maintaining an optimal level of knowledge to effectively perform the study activities:
• Acquire and maintain an appropriate level of knowledge on the pathology of disease area being studied, the study compound, the study protocol and all study related activities;
• Attendance at internal project meetings and relevant training courses;
• Keep up to date with all the changes / required knowledge on ICH GCP, GSK written standards and attending appropriate training sessions.
- Have regular interactions with relevant functions from the GSK Regional and Central team such as Study teams, business system owners etc.;
- Requirement to interact and collaborate with GSK LOC staff such as Study managers, medical staff, LCSSs and Quality and Training Manager;
- Requirement to communicate and work effectively with medical staff/physicians/scientists who are often senior within their field, being mindful of their standing within the medical and/or research community;
- Interactions with key partners including ethics boards, pharmacies, vendors.
• Higher education (medical, biological, pharmaceutical);
• 1.5-2.5 years of experience as a monitor of clinical trials;
• Good clinical monitoring skills;
• Experience in cancer projects will be an additional advantage for the candidate;
• English - Intermediate;
• Experience with electronic registration cards and IVRS/IWRS systems.
• Readiness for business trips (50% of working time);
• Good communication skills, presentation skills, willingness to learn, responsibility and diligence.
GlaxoSmithKline- is one of the world's leading over-the-counter healthcare companies. We hold number one positions in Wellness across 36 markets, and are market leaders in specialist oral care.
Our aim - to help as many people as possible do more, feel better, live longer.
Our history started 150 years ago. We are owners of the most popular brands in the world such as Sensodine®, Coldrex®, Voltaren®, Theraflu®, Parodontax®, Corega®, Otrivin®, Phisiogel® and so on.
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