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- FSP Site Activation Partner II
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FSP Site Activation Partner II
Parexel International Corporation
Mexico - Any Region - Home Based
Position Purpose:
o The Site Activation Partner II (SAP II) is responsible for leading or supporting operational activities
from start-up to close-out, for assigned studies and investigator sites to ensure compliance with
study timelines and in accordance with prevailing laws.
Primary Duties:
Clinical Trial Site Activation & Conduct
o Initiate and coordinate activities and essential documents management towards the compilation of
a high-quality Investigator Initiation Package (IIP) leading to sites initiation approval
o Register investigator sites in Client registries and systems as required. Update and regularly
maintain the registry with accuracy and have it inspection ready
o Work directly and interact with investigator sites to complete critical information and readiness for
site activation; inclusive of but not limited to IIP essential documents components, study contracts
contacts, clinical supply shipment information, payment information, IRB submission and status
o Take the lead to resolve issues or concerns and timely escalation of issues where applicable
o Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms,
FDA 1572 revisions, for internal regulatory approval within required
timelines
o Lead a subset and assist with the overall site activation process and coordinate operational
activities to ensure timely site activation
o Take the Lead and Coordinates the compilation of the Central IRB package and submissions to
approval of the study
o Coordinate the timely communication, documentation and responses between Client and Central
Ethics committee to bring clinical study to approval
o Support investigators sites with local IRB workflow from preparation, submission through approval
o Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of
tracking information
o Initiate and coordinate activities and essential documents management with the investigator’s sites
(post site initiation visit (SIV)) during study conduct towards the compilation of a high-quality
documents and updates through the life cycle of a study such as the documents management for
protocol amendments, FDA 1572 revisions, Ethics Committee annual approvals
o Responsible for timely filing of documents to Trial Master File and other systems and assist with
periodic quality review of study files for accuracy and completeness
o Lead or assist with the preparation, handling, distribution, filing, and archiving of clinical
documentation and reports according to the scope of work and standard operating procedures.
o Supports investigator sites, and study teams in preparation for and providing responses to site
audits/inspections
Communication
o Maintain ongoing contact and communication with the study team and respond promptly to study
team and investigator site requests
o Attend study Start-up meeting and provide functional updates on a country and site level
o Disseminate Central Ethics Approval to study team and Investigator Sites
o Communicate Local sites approvals
Clinical Trial Site Support
o As needed, perform investigator site development, coaching and training of site personnel to
ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good
Clinical Practices, and Client standards
o Identify and resolve investigator site issues within required timeframes; agree and develop
corrective and preventative actions with investigator and site personnel
Additional Responsibilities:
o Deep understanding of the Site Activation requirements and processes within the country and be
able to develop and implement in more than one country
o Represent the SAP role on the study
o Communicate with SAPs globally on study information and timelines
o Be an SME on one or more system and/or process, be the go-to person and train the SAPs on
these respective systems or processes
o Mentor for new hires on processes
o Able to manage a high volume of, complex studies and sites
QualificationsSkills and Education:
o School diploma/certificate with equivalent combination of education, training and experience;
BS/BA or bachelor’s degree in life sciences preferred
o Minimum 6 years relevant experience in Clinical Trials environment and clinical site activation. Experience working in the pharmaceutical industry/or CRO is an asset
o Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local
country regulations
o Must be fluent in Local language and in English.
o For individuals based in Canada: Bilingualism (French, English) is an asset
o Effective verbal and written communication skills in relating to colleagues and associates both
inside and outside of the organization
o Good technical skills and ability to learn and use multiple systems
o Experience working in a global environment
o Experience in working in more than 1 country is an asset
o Demonstrated knowledge and understanding of key operational elements of a clinical trial and
processes (e.g., study start-up, conduct, close-out activities, reporting, etc.) and ability to gain
command of these processes
o Understand the quality expectations and emphasis on right first time. Demonstrate compliance with
all applicable company, regulatory and country requirements. Attention to detail evident in a
disciplined approach
o Proven ability to work independently and also as a team member
o Ability to organize tasks, time and priorities, ability to multi-task
o Understand basic medical terminology, GCP requirements and proficient in computer
operations.
Job posted: 2021-05-04