Site Monitor

5 months ago


Remote, United Kingdom Parexel Full time

United Kingdom, Remote

**Job ID** R0000018004

**Category** Clinical Trials

**ABOUT THIS ROLE**:
Parexel are currently recruiting for a sponsor dedicated Site Monitor.

The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. The Site Monitor will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready and will coordinate with institutions and investigators at the local level.

**Some specifics about this advertised role**

**_ Oversight of Monitoring Responsibilities and Study Conduct_**
- Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes.
- Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations.
- Conducts source document review and verification of appropriate site source documents and medical records. Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete.
- Manages reporting of protocol deviations and appropriate follow up.
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
- May perform Investigational Product (IP) inventory, reconciliation and reviews storage and security.
- Applies knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released and returned.
- Manages reporting of identified issues and manages follow up to resolution.
- Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP.
- Ensures all activities are managed by site personnel who are appropriately delegated and trained.
- Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site level activities and communication to ensure project objectives, deliverables and timelines are met. (Must be able to quickly adapt to changing priorities to achieve goals and targets).
- Reviews data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks.
- Reviews site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study, review and assess training compliance with any new and updated training requirements (i.e., protocol amendment(s), etc.)
- Conducts follow up for escalated adverse event monitoring (AEM) report queries.
- Checks the site and external facilities, equipment, and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable).
- Checks site specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, IP Accountability Log).

**_ Collaboration_**
- Collaborates with primary Site Manager who will act as the primary liaison with site personnel.
- Prepares for and attends Investigator Meetings and sponsor face to face meetings.
- Participates in global clinical monitoring and project staff meetings (inclusive of client representation, as applicable) and attends clinic.

**Who are Parexel?**

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

**What we are looking for in this role**

For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart.

Here are a few requirements specific to this advertised role.

**Skills**
- Networking and relation



  • Remote, United Kingdom ICON Full time

    **Title - Site Engagement Liaison** **Location - UK wide (4 site visits per month)** **Fully sponsor dedicated** As a Site Engagement Liaison you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **This role would suit a senior CRA looking to gain oversight experience and...

  • Site Care Partner I

    5 months ago


    Remote, United Kingdom Parexel Full time

    United Kingdom, Remote **Job ID** R0000020486 **Category** Clinical Trials **ABOUT THIS ROLE**: Parexel FSP has an exciting opportunity for a Site Care Partner I in the UK. **Job Summary**: The Site Care Partner I (SCP) is the main client point of contact for investigative sites throughout a study life cycle; accountable for site start-up activities...


  • Remote, United Kingdom Eriks Full time

    Role: Site Services Supervisor Location: Hampshire ABOUT THE ROLE - Directly lead, manage and drive forward the technical service offering of the Southampton/South Coast Engineering team as the primary point of contact with clients, understanding their requirements, aims, schedules and processes to ensure full - and on-time delivery of services and...


  • Remote, United Kingdom Thermo Fisher Scientific Full time

    **Senior/CRA - United Kingdom** PPD, part of Thermo Fisher Scientific are currently hiring for CRAs in the following UK locations: Scotland (central belt), North West England, South West England, Midlands, and Wales. At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in...


  • Remote, United Kingdom AL Solutions Full time

    AL Solutions is currently seeking a highly skilled and experienced Clinical Research Associate II/Senior CRA to join our team in the Midlands region. In this role, you will play a pivotal role in overseeing and managing clinical trials for our pharmaceutical and biotechnology clients. As a CRA II/Senior CRA, you will be responsible for monitoring site...


  • Remote, United Kingdom Syneos Health Clinical Full time

    **Description** **Clinical Trial Manager II** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...

  • Senior Cra

    5 months ago


    Remote, United Kingdom ICON Full time

    As a Senior CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - Act as liaison between the in-house team, vendors, and multiple clinical sites. - Work collaboratively with investigative sites to develop strong, long-term, working...


  • Remote, United Kingdom AL Solutions Full time

    Jordan Griffiths is currently seeking a highly motivated Clinical Research Associate (CRA) to join our top CRO client. As a CRA, you will be responsible for the execution and management of clinical trials across various therapeutic areas in South West England. **Key Responsibilities**: - Conduct site initiation, monitoring, and close-out visits - Ensure...


  • Remote, United Kingdom Cala Consulting Limited Full time

    **Environmental Consultant - remote role/client sites based in UK/Ireland** **The role** Your role will include: - Managing Environmental Monitoring Programmes. Allocating resources to undertake monitoring programmes for clients, reviewing results and compiling reports. - Input into Environmental Impact Assessments. - Compiling Construction Environmental...


  • Remote, United Kingdom Parexel Full time

    Parexel is currently seeking a Clinical Research Associate II in the UK. This will be a home-based position. Working as a Clinical Research Associate II at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible...


  • Remote, United Kingdom Aberdeen Appointments Agency Full time

    Our client is looking for a Temporary Project Logistics Coordinator to join their team To provide project co-ordination and logistics support to allocated projects. This is a role that can be worked remotely would be required for a period of around 4 months. **Responsibilities** **Project Coordinator Support** - Understanding contractual terms and...


  • Remote, United Kingdom Cancer Research UK Full time

    4,000 professionals, 0 days wasted, 1 incredible purpose. Together, we are beating cancer._ Clinical Research Associate **Salary**: £38,000 - £42,000 pa depending on experience Department: Research and Innovation Location: Home Based (UK) Hours / contract type: Fixed Term Contract for 18 months - Full time 35 hours (flexible working requests...

  • Part-time Bookkeeper

    5 months ago


    Remote, United Kingdom DCS Services LTD Full time

    Process purchase ledger and sales ledger transactions in an accurate and timely manner. CIS returns. Monitor and report on all company direct debits and standing orders. Manage the dedicated client inbox, act on a client query immediately and work through to resolution. Monitor and report on client ledgers and credit limits. Process VAT returns and...


  • Remote, United Kingdom IQVIA Full time

    **Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. **_At least 3 years' experience with submissions....


  • Remote, United Kingdom SoundHR LTD Full time

    Opportunities at Circet **Position**: Traffic Management Operative - FREEFLOW -East Kilbride Full Time Permanent **Main Purpose**: Reporting to the Operation Manager, the TM operative will be responsible for the install, maintenance and removal of all site-based traffic management activities. Working with Freeflow Traffic Management. Key...

  • M&e Clerk of Works

    6 months ago


    Remote, United Kingdom ATS Recruitment Limited Full time

    **M&E Clerk of Works** **Oxford** **Freelance - Part time** **The Client** Our client is an award-winning multi-disciplinary consultancy in the UK Construction sector with over 30 years of experience ensuring residential and regeneration for local authority and residential clients are built and delivered to the highest quality. Our client provides clerk...


  • Remote, United Kingdom Remote Medical Inc. Full time

    **Remote Healthcare Provider (RHCP)** with Global Wind Organisation training. **ROLE SUMMARY** This position will be responsible for the management of emergent and non-emergency medical care at worksites as designated by the client or content of the scope of work (SOW). Examples of such worksites may include but are not limited to, drilling rigs, hazardous...


  • Remote, United Kingdom IQVIA Full time

    We have great opportunities for those with a background working in Clinical Trials, preferably with a focus on patient recruitment/engagement, to join our Site and Patient Networks team. **PURPOSE** Assist Patient Recruitment Leads and manage assigned tasks related to the coordination, planning, and implementation of Patient Recruitment and Retention...

  • SEO Lead

    5 months ago


    Remote, United Kingdom Pitchup.com Full time

    Want to work with an award-winning and quickly expanding company? We’re the leading website for outdoor holidays, making it a doddle to book camping, glamping and caravan sites all over the world, with over 5,300 to choose from. **As SEO Lead, you will champion, spearhead and report against our global SEO efforts**. With around 30m bednights already sold,...


  • Remote, United Kingdom MAC Clinical Research Full time

    MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We are now seeking to appoint a Source Document Specialist to join our dedicated team. This is a remote role with travel to sites as...