FSP Site Activation Partner II

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.