Senior CRA- TX

Pharmaceutical Research Associates, Inc

103d

About The Position

As a Senior CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Requirements

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience preferred.
• Read, write and speak fluent English; fluent in host country language required.
• 4+ years of clinical monitoring experience required.
• Knowledge of ICH and local regulatory authority regulations regarding drug.
• Clinical research experience.
• Experience in monitoring all trial components (PSSV to COV).
• Experience in coaching/mentoring other CRA.

Responsibilities

• Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing.
• Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.
• Strong planning & organizational skills, and the ability to work efficiently and effectively.
• Proactive, conscientious and precise in delivery of quality work even when under pressure.
• Effective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timely manner.
• Flexible with high learning and change agility.
• Knowledge of local regulations, IND/ICH GCP - guidelines.
• Available and willing to travel as job requires.
• 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 effectiveness.
• 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 and site close-out.
• 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 requirements for clinical studies.
• Works with Study staff to carry out a local study / site level risk.
• Participate in global investigators and/or monitor meetings as appropriate.
• Facilitates investigator’s participation in global meetings and/or may assist the study staff with organizing local investigator.
• Participates in other study meetings as required.
• Maintain good relationship with sites 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).
• 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 and entered in real time.
• 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 safety department and other relevant departments, within the required time frames.
• Completes monitoring visit reports within the agreed timelines.
• Ensure local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track, Veeva, RAMOS).
• 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 sponsor study records are inspection ready at all times and archives records as applicable.

Benefits

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

What This Job Offers

• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees