Performs remote site management and monitoring activities on assigned project(s) in accordance with FDA and/or local regulations and guidelines, ICH GCPs and PPD procedural documents. Reviews study data from various sources remotely. Contacts study sites to collect study documentation, resolves issues and requests outstanding information.
Performs clinical monitoring visit report review, approval and finalization activities including activation of the Site Health Assessment tool, as appropriate, on assigned project(s) in accordance with FDA and/or local regulations and guidelines, ICH GCPs and PPD procedural documents. Performs site risk assessment activities on assigned project(s) and collaborates with study teams to resolve issues. Works proactively and independently, requiring minimal supervision.
Major Job Responsibilities:
- Performs review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or regions and escalates any protocol, site, and/or CRA issues or trends noted during the report review process to CTM.
- Liaises with CRA for prompt trip report review submission and approval as per the stipulated timelines of PPD and/or the Sponsor. Plays an active role on the project team to help ensure compliance with monitoring visit report expectations
- Reviews and customizes the Monitoring Report Templates for allocated projects
- Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes to assess site’s ability to conduct study, as ascertained from information noted in monitoring visit reports and associated electronic data systems.
- Supports the CTM with the activation and ongoing review of Site Health Assessments and attends applicable Project meetings pertaining to all levels Central Review Manager related topics
- Provides trial MVR status tracking and progress update reports to CTM/CRA as required.
- Conducts assessment of SHA and site risk and provide thorough feedback to the CTM.
- Assists in ensuring audit ready files. Contributes to company, client, and federal/local regulatory requirements/audit responses as needed.
- Remotely reviews EDC (with or without source verification, depending on local practice and regulations). Performs source data verification from web-based sources where possible, and in compliance with local laws.
- Remotely reviews drug accountability log.
- Conducts and documents site management contacts according to the monitoring plan.
- Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study.
- Provides refresher training, follows up on outstanding administrative needs (e.g., outstanding/updated regulatory documents), assists with regulatory reviews, as requested, updates CTMS with site contact changes and maintain vendor tracker.
- Reviews and appropriately escalates site key risk/performance/quality indicators (KRI, KPI, KQI [e.g., early termination and screen-fail rates, average number of open findings, etc.]) , ad-hoc clinical listings review, tracks and trends violations and deviations, ensures visits occurred per the MP, site status, enrolment, CRF status and SAE follow up.
- Provides trial status tracking and progress update reports to CTM as required.
- Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System – CTMS).
- Liaises with CRA to promptly collect documents, reviews data points, findings from EDC and file reviews, etc.
- Conducts remote investigations into site performance issues at the directive of the CTM.
- Writes, follows and resolves clinical queries and issues.
Education and Experience:
- Bachelor’s Degree in a life science-related field or relevant/equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
- Prior clinical research experience of 3 to 5 years as well as mandatory experience of on-site clinical monitoring or on site CRA of 3 to 4 years
- Experience through classwork/training that provides the required knowledge skills and abilities.
In some cases, previous experience in a clinical environment where experience is gained in clinical trials, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
Knowledge, Skills and Abilities:
- Good therapeutic area knowledge and understanding of medical terminology by virtue of past training of a CRA
- Ability to attain and maintain a working knowledge of FDA and/or local country regulation and guidelines, ICH GCPs and PPD procedural documents
- Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP)
- Highly effective oral and written communication skills with the ability to communicate effectively with project team members
- Excellent organizational and time management skills
- Ability to work in a team or independently or as home based, as required
- Ability to write clinical monitoring visit reports, review or approve them and interpret the information captured in clinical monitoring visit reports
- Ability to extract pertinent information from protocols, electronic study data systems, CTMS, dashboards and assess risk at site level through interpretation of all these data
- Excellent English language and grammar skills
- Ability to mentor junior team members, as needed