Job Description

Description

FSP Pfizer Sr. CRA, South Africa
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.


Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.


Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.


Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Responsibilities

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-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 in collaboration with other sponsor roles to achieve Site Ready. Participates & provides inputs on site selection and validation activities. Performs remote and on-site monitoring & oversight activities using various tools to ensure:

o Data generated at site are complete, accurate and unbiased

o Subjects' right, safety and well-being are protected

Conducts site visits including but not limited to validation visits, 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 required regulatory documentation for 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 site performance.

Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM, PLM and RCPM. Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. Supports and/or leads audit/inspection activities as needed

What we're looking for:

Min B.A./B.S. required with strong emphasis in science and/or biology coupled with relevant work experience Several years of direct site monitoring experience in Oncology, in a bio/pharma//CRO in Sr CRA level Fluent in German and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. Hands on knowledge of Good Documentation Practices Proven Skills in Site Management including management of site performance and patient recruitment Demonstrated high level of monitoring skill with independent professional judgment. Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. Ability to understand and analyze data/metrics and act appropriately Willingness to perform an average of about 8 monitoring visits per month within Germany and you may get asked to cover the German part of Switzerland as well potentially from time to time

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.


No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.


http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the . The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

JOB SUMMARYThe Senior Clinical Research Associate I (SCRA I) will perform monitoring and site management activities for Phase IIVclinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (eitheron site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with theprotocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federalregulatory requirements. Performs all tasks routinely and independently. May assume clinical functional leadership tasksas assigned, acting as Lead CRA for a project or assessor of peers for sign-off visit purposes (as approved).JOB RESPONSIBILITIES- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site orremotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendationsregarding site-specific actions; immediately communicates/escalates serious issues to the project team and developsaction plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations,and company SOPs/processes.- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assessesfactors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such asprotocol deviation/violations and pharmacovigilance issues.- Per the Clinical Monitoring/Site Management Plan (CMP/SMP): - Assesses site processes- Conducts Source Document Review of appropriate site source documents and medical records- Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site sourcedocuments and medical records- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving queryresolution to closure within agreed timelines- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture- Verifies site compliance with electronic data capture requirements- May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP hasbeen dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associatedwith blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizationalprocedures to ensure IP is appropriately (re)labelled, imported and released/returned.- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents ofthe ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archivingessential documents in accordance with local guidelines and regulations.- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other requiredproject documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patientrecruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations,ongoing status and assigned action items to resolution.- Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-levelactivities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adaptto changing priorities to achieve goals / targets.- May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures allassigned sites and project-specific site team members are trained and compliant with applicable requirements.- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, withsupervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) andattends clinical training sessions according to the project specific requirements.- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit andrequired follow-up actions.- May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff,as assigned.- May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical OperationsLead (COL), or operational line manager.- For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I.Additional responsibilities include: - Site support throughout the study lifecycle from site identification through close out- Knowledge of local requirements for real world late phase study designs- Chart abstraction activities and data collection- As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and localcountry staff- Identify and communicate out of scope activities to Lead CRA/Project Manager- Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health CareProvider (HCP) associations- Identify operational efficiencies and process improvements- Develop country level informed consent forms- Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared- Participate in bid defense meetingsQualifications - InternalQUALIFICATION REQUIREMENTS- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements- Must demonstrate good computer skills and be able to embrace new technologies- Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected.- Ability to manage required travel of up to 75% on a regular basisDisclaimer:Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretionand with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/oreducation will also be considered so qualifications of incumbents may differ from those listed in the .The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with allobligations imposed by the legislation of each country in which it operates, including the implementation of the EUEquality Directive, in relation to the recruitment and employment of its employees