Lead CRA

An established biotechnology company is advertising a vacancy for a Lead Clinical Research Associate position based in Stevenage. The company develops next-generation, patient-specific therapeutics that allow scientists to combat cancer without harming healthy tissues. This is an exciting opportunity to work with a dynamic and revolutionary organisation.

Job Responsibilities:

• Expedite the site qualification and study site initiation processes including the conduct of Site Qualification and Site Initiation visits.
• Conduct Site Initiation visits in collaboration with Medical Monitors and/or Clinical Project Managers, where applicable, to regularly orient and train site personnel regarding the protocol and applicable regulatory requirements.
• Independently perform monitoring visits including site initiation, qualification, routine monitoring, and close out visits.
• Critically review and analyse site activities through frequent visits and contacts to monitor study sites following the applicable study plans and applicable SOPs, to assure compliance with the protocol, JCH and/or FDA GCP Guidelines and other local regulations; this includes, but is not limited to:
• the on-site confirmation of the source data verification of CRFs
• Data clarification forms as stipulated
• Manage multiple protocols across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory
• Ensure quality of data submitted from study sites, collect data from sites within established timelines, and ensure timely follow up/submission on any requested information.
• Work across functions in the Company to ensure the readiness of supply kits.
• Ensure site compliance, safety, and protection of study patients according to the clinical study plans, SOPs, and ICH, and/or FDA GCP Guidelines.
• Work with site personnel/study team to prevent address and resolve issues.
• Review adverse event reports (where required) and ensure site reporting of safety events in a timely manner.
• Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, and objective manner.
• Interact and build professional and collaborative relationships with all study personnel (study coordinator, investigator, pharmacist & cell therapy team members), peers, and office-based personnel.
• Supervise overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives.
• Provide full support to study sites to facilitate study conduct successfully
• Proactively communicate and escalate with all internal and external stakeholders any serious or outstanding issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.
• Ensure documented follow-up to all outstanding issues, within the scope of this position profile.
• Anticipate and proactively solve study site problems/issues as they occur. Initiate, recommend, and communicate corrective actions as needed.
• Identify, evaluate, and recommend potential investigators/sites on an on­ going basis to assist in the placement of planned clinical studies with qualified investigators.
• If required, prepare, coordinate, and present at Investigator meetings and other study trainings.
• Maintain up to date self-training e.g. ICH GCP and flag new/changes to site and clinical operations team.
• Facilitate the Regulatory Compliance audit process, as needed.
• Provide monitoring assistance to site monitor colleagues, as requested, in addition to serving as a mentor to other colleagues as assigned.
• Uses multiple technologies to foster, maintain, and enhance open communication.
• Available for travel up to 60% of the time, including overnight stays, as necessary.
• Any other ad-hoc tasks as required
• Adhere to all health and safety guidance provided by the company.

Skills and Requirements:

• Bachelor's degree (BSc, BA, or RN equivalent) in biological or science-related field is essential.
• A valid driving licence.
• Previous small pharmaceutical/biotech experience preferred.
• Minimum of 3-5 years' monitoring experience, working as a CRA.
• Experience in monitoring oncology early phase studies.
• Experience with ATIMPs an advantage.
• Strong clinical, technical, or disease area expertise.
• Knowledge of medical terminology and clinical patient management.
• Thorough knowledge of ICH Guidelines and GCP, including a basic understanding of regulatory requirements.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Joshua Godden at +44 2038540101 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-JG1

#ClinicalResearch