- Acts as primary local company contact for assigned sites for specific trials
- May participate in site feasibility and/or pre-trial site assessment visits
- Attends/participates in investigator meetings as needed
- Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits
- Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe
- Assists with site level recruitment strategy and contingency planning and implementation in partnership with other functional areas
- Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct
- Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented
- Arranges for the appropriate destruction of clinical supplies
- Ensures site staff complete data entry and resolve queries within expected timelines
- Ensures accuracy, validity and completeness of data collected at trial sites
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents
- Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management
- Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders
- Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times
- Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team
- Attends regularly scheduled team meetings and trainings
- Complies with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities
- Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV)
- Prepares trial sites for close out, conduct final close out visit
- Tracks costs at site level and ensure payments are made, if applicable
- Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff
- May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate
- Acts as a point of contact in site management practices
- May contribute to process improvement and training.
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Site Manager, Oncology - Raritan, United States - Johnson & Johnson
Description
Janssen Research & Development, LLC, is recruiting for a Site Manager, Global Clinical Operations - Oncology to be remote in the Western Region ( AZ, CA, CO, ID, MT, NE, ND, NM, NV, OR, SD, UT, WA, WY, HI, AK) of the United States.
A Site Manager I (SM I) serves as the primary contact point between the Sponsor and the Investigational Site.
A SM I is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure.
Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities.
The SM I will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols.
May assist in process improvement and training.At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more atKey Responsibilities:
