Site Activation/ Study Start Up

MUST CURRENTLY WORK AT A CRO/PHARMA

Must have Study Start up experience

Responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites/studies to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and standards.

You will provide technical and logistical support to the SRPs to deliver Investigator Initiation and Study Start Up.

Responsibilities

Clinical Trial Site Activation & Conduct

Assist with study site activation activities to ensure timely site activation.

Register investigator sites in egistries as required.

Support and/or coordinate central Investigator Review Board (IRB) submissions when needed.

Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status.

Support local IRB workflow from submission through approval and support reporting of updates to safety information.

Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner.

Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions, for internal regulatory approval within required timelines.

Communicate site approvals to the SRPs, Study Start Up Project Managers (where applicable) and relevant study team members.

Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed.

Work with investigator sites throughout the study to complete required ongoing study documents such as documents for protocol amendments and FDA 1572 revisions.

Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.

Submit within required timeframes all needed documentation, updates and tracking including, but not limited to, Trial Master File documentation, site activation status, protocol amendment status.

Problem solve identified issues with appropriate timely escalation to the SRP.

Assist the SRP with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Support investigator sites, SRPs, Study Managers and study teams in preparation for and providing responses to site audits/inspections.

Communication

Act as a point contact for the GSSO team members for designated project site communications, correspondence and associated documentation.

Maintain ongoing contact and communication with the GSSO team members as needed.

Respond promptly to GSSO team member and investigator site requests.

Establish tools for efficient updates to the GSSO Study Team members as needed regarding site status, issues, delays, and approvals.

Clinical Trial Monitoring Support

As needed, support the SRP with coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices, and standards.

In collaboration with the SRP, conduct or oversee investigator site activation activities, IIP completion, site budget and contract negotiation, and ensure timely management of emerging issues that may compromise time to site activation.

In collaboration with SRP and Outsourcing Lead, facilitate site payments as needed and as per contracts and work with the appropriate groups to resolve issues.

In support of SRP, conduct remote monitoring activities, with a focus on Trial Master File/Site Master File reconciliation, investigational product reconciliation or other technical or logistical supportive activities that facilitate inspection readiness.

Identify and resolve in collaboration with Site Relationship Partner investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues.

Assist to resolve data queries within required timelines; support database release as needed for supported sites/functions.

Required skills:

Minimum of 2 years of related experience

Experience with PC-Windows, word processing, and electronic spreadsheets required.

Knowledge of ICH and local regulatory authority drug research and development regulations required.

Clinical trials support or pharmaceutical industry experience required.

PREFERRED School diploma/certificate or equivalent combination of education, training and experience; BS/BA or Bachelor’s degree in life sciences preferred. In general, candidates for this job would hold the following levels of education/experience:

2 years relevant experience in clinical site management

Experience in study activation and site management is an asset

Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations

Must be fluent in English, and the regulatory language of the appointed location

Skills

Demonstrated knowledge of global and local regulatory requirements

Demonstrated understanding of key operational elements of a clinical trial (e.g., study start-up, conduct, close-out activities, reporting, etc.)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 to document review, adherence to SOPs, metrics, etc.

Proven ability to work independently and, also as a team member

Ability to organize tasks, time and priorities, ability to multi-task

Understand basic medical terminology, GCP requirements and proficient in computer operations.

Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

Required to support multi-national team members, and flexibility in working hours may be needed occasionally