Clinical Research Associate Senior

TheClinical ResearchAssociate Sr(CRA SR) role is accountable forperformanceand compliance for assigned protocols and sites in a country.

Under the oversight of the CRAmanagerthe person ensures compliance of study conduct withICH/GCPand country regulations, our companypolicies and procedures, quality standards andadverse event reportingrequirements internally and externally. Acts as primary site contact and sitemanagerthroughout all phases of aclinical researchstudy, taking overall responsibility of allocated sites. Actively develops and expand the territory forclinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

Responsibilities include, but are not limited to:

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical studysite management/monitoring activities in compliance withICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks incollaborationwith other sponsor roles to achieve Site Ready.
• Participates & provides inputs onsite selectionandvalidationactivities.

Performs remote and on-site monitoring & oversight activities using various tools to ensure:

• Data generated at site are complete, accurate and unbiased.
• Subjects' right, safety and well-being are protected.
• Conducts site visits including but not limited tovalidationvisits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors requiredregulatory documentationfor study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations,regulatory documentation, site audits/inspections and overall siteperformance.
• Identifies, assesses and resolves siteperformance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate incollaborationwith CRAmanager,CRM, and RCPM.
• Manages and maintains information and documentation inCTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes to CRA team knowledge byactingasprocessSubject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
• Supportsand/or leads audit/inspection activities as needed.
• Following the countrystrategydefined by CRD and CRAmanager, contributes to the identification of new potential sites and works closely with them to develop strongclinical researchcapabilities.

"This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement."

Experience Requirements:

• Experience in directsite management(monitoring), experience in a bio/pharma/CRO.
• Previous experience inOncology clinical researchstudies.

Educational Requirements:

• Preferred: B.A./B.S. with strong emphasis in science and/or biology.

Competency Expectations:

• Fluent inPortugueseandEnglish(verbaland written) andexcellent communication skills, including the ability to understand and presenttechnical informationeffectively.
• Good understanding and working knowledge ofclinical research, phases ofclinical trials, currentGCP/ICH& countryclinical researchlaw & guidelines.
• Good understanding of Global, Country/RegionalClinical ResearchGuidelines and ability to work within these guidelines.
• Hands on knowledge ofGood Documentation Practices
• Proven Skills inSite Managementincluding management of siteperformanceandpatient recruitment
• Demonstrated high level of monitoring skill withindependentprofessionaljudgment.
• GoodIT skills(Use of MS office, use of various clinicalITapplications on computer, tablet and mobile devices) andability to adaptto newITapplications on various devices
• Ability to understand and analyse data/metrics and act appropriately
• Effective time management,organizationalandinterpersonal skills,conflict management,problem solving skills
• Able to work highly independently across multiple protocols, sites and therapy areas
• High sense ofaccountability/ urgency. Ability to set priorities and handle multiple tasks simultaneously in achanging environment
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships
• Demonstrates commitment toCustomer focus
• Works with high quality and compliance mind-set
• Ability to travel domestically and internationally approximately 65%-75% of working time.
• Expected travelling 2-3 days/week.

Requisition ID:P-100443