Vaga de Sr CRA I - Brazil Home Based
1 vaga: | Publicada em 26/04
- A Combinar
Sobre a vaga
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, youll 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 were able to create a place where
everyone feels like they belong.
Job responsibilities
Performs site qualification, site initiation, interim monitoring, site management
and close-out visits (performed on-site or remotely) 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 recommendations regarding site-specific actions; immediately
communicates/escalates serious issues to the project team and develops action
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. Assesses
factors that might affect subject/patients safety and clinical data integrity at
an investigator/physician site such as protocol 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 source documents and medical records
Applies query resolution techniques remotely and on site, and provides guidance to
site staff as necessary, driving query resolution 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 has been dispensed and administered to
subjects/patients according to the protocol. Verifies issues or risks associated
with blinded or randomized information related to IP. Applies knowledge of
GCP/local regulations and organizational procedures 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 of the ISF with the Trial Master File (TMF).
Ensures the investigator/physician site is aware of the requirement of archiving
essential documents in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow-up letters, trip reports,
communication logs, and other required project documents as per SOPs and Clinical
Monitoring Plan/Site Management Plan. Supports subject/patient recruitment,
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-level activities / communication to ensure
project objectives, deliverables and timelines are met. Must be able to quickly
adapt to changing priorities to achieve goals / targets.
May act as primary liaison with project site personnel, or in collaboration with
Central Monitoring Associate. Ensures all assigned 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, with supervision, lead, global clinical
monitoring/project staff meetings (inclusive of Sponsor representation, as
applicable) and attends 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 and required 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 Operations Lead (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 local country 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 Care Provider (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 meetings
Qualifications
What were looking for
Bachelors 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 basis
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, youll take the initiative and challenge the status
quo with us in a highly competitive and ever-changing environment. Learn more
about Syneos Health .
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 Job Description. 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.
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