FSP Clinical Research Associate 2

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job-related skills

− Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation, influencing and site engagement skills.

− Is a self-starter and able to work within remote teams and independently.

− Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.

− Good interpersonal skills, including managing difficult conversations with Investigator & site staff, ability to discuss site trends.

− Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment.

− Respects confidentiality in terms of Personal Information (PI)/ Personal Health Information

− Proactive, conscientious, and precise in delivery of quality work even when under pressure

− Effective at analysing and escalating issues at the right functional level, solving problems using critical thinking and performing root cause analysis and resolving conflicts in a timely manner.

− Flexible with high learning and change agility.

− Proficient in Risk Based Quality Management, comfortable utilizing GSK’s RBQM systems/tools to inform on site risk and guide monitoring visit, process-based site management.

− Collaborative, building strong internal and external relationships.

− Knowledge of local regulations, IND/ICH GCP - guidelines,

− Available and willing to travel as job requires and the ability and willingness to learn and master new or evolving computer systems to support business requirements effectively.

− Strong computer skills with good eye for detail.

Job responsibilities

− Communicate the progress and relevant information or escalate issues of the study to the appropriate study management team in a timely manner.

− Engage and maintain good written and verbal communication with external and internal stakeholders in order to ensure effective study execution.

− Accountable for local activities required in site 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 and site close-out 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 Investigator and site staff have robust processes for conducting the current protocol (GSK standard and study-specific)

− Confirms ability to comply with ICH GCP and GSK requirements for clinical studies.

− Works with GSK Study staff to carry out a local study level risk assessment, accountable for site risk assessment.

− 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 GSK study staff with organizing local investigator meetings. Participates in other study meetings as required.

− Maintain good relationship with Investigator and site staff and 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.

− Ensure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP) including Investigator oversight and appropriate delegation.

− Lead and encourage site accountability for ongoing, robust subject recruitment & retention discussions with Investigator and site staff, including recruitment planning, barriers to recruitment, potential mitigations.

− Conducts monitoring visits in accordance with Trial Monitoring Plan; monitors to confirm adherence to described site process (GSK standard & study-specific); prepare in advance of monitoring visit by utilizing GSK’s RBQM system/tools to inform on site risk and guide monitoring visit.

− Able to successfully conduct remote/off-site monitoring visits using all tools available for remote/offsite tasks.

− Work with sites to ensure timely data entry and data query resolution.

− Ensure source documents adhere to ALCOAC+ standards, ensure filing and review of source documentation in the appropriate location in the eTMF in a timely manner and ensure adherence to site stated processes (GSK standard & study specific)

− Ensure Investigator and site staff receives safety reports and reviews new safety information in a timely manner.

− Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to GSK safety department and other relevant departments, within the required time frames.

− Completes high quality monitoring visit reports within the agreed timelines, ensuring the report reflects the conduct of the visit; escalating important issues promptly via phone/email

− Ensure local and global clinical study tracking databases are kept current with clinical study information as required (i.e., EDC, CTMS, IRT).

− Investigate trends/findings from GSK Central Monitoring group with Investigator and site staff, determining root cause and actions needed and provide information back to Central Monitoring, as requested.

− Ensure all necessary study supplies 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 site is meeting quality requirements and is inspection ready at all times.

− Ensure sponsor study records are inspection ready at all times and archives records to ensure compliance with GSK TMF submission timelines.

− Knowledge of local regulatory environment e.g. If working in Europe, knowledge of EUCTR process and documentation required

− Review of KRI data within the GSK RBQM systems to inform on site risk and guide monitoring visit, process-based site management adequately.