Clinical Research Associate – Early Phase
Expiry Date :
Mon, 21 Jun 2021 23:59:59 GMT
Apply Job :
Achilles Therapeutics is a high growth clinical-stage biopharmaceutical company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. Originating from pioneering research at Cancer Research UK (CRUK), the Francis Crick Institute and University College London (UCL), we use DNA sequencing data from each patient, together with our proprietary PELEUS bioinformatics platform, to identify clonal neoantigens specific to that patient. From this, we develop personalised T cell therapies and currently have two programs in the clinic for the treatment of Non-Small Cell Lung Cancer and Metastatic Malignant Melanoma.
As a company, we are fast-paced and trailblazing. We are breaking new ground with our science, creating products that have never been made. As no-one has done what we are doing before, there is no playbook to copy. This means we must innovate, adapt and collaborate across our organisation, working together to solve novel problems. This entrepreneurial spirit and approach run through our company and those who thrive here are able to cope with anything that is thrown at them, enjoy ambiguity and thrive on making things happen even when there is not a detailed brief. We work hard and deliver a lot.
You will be joining a growing UK based biotech company, which is opening a US HQ in the greater Philadelphia/NJ area. The company which is developing neoantigen therapy for oncology indications. You would become one of the members of their close-knit team, responsible for all aspects of study site management. Ideal for an experienced CRA who has early phase, oncology study monitoring experience, preferably in the cell therapy arena.
* Support the PM/Sr. PM in the site qualification and study site initiation processes including the conduct of Site Qualification and Site Initiation visits.
* Conducts Site Initiation visits in collaboration with Medical Monitors and/or Clinical Project Managers where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements regularly.
* Independently performs monitoring visits including site initiation, qualification, routine monitoring and closeout visits
* Critically reviews and analyses 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, and IRB requirements.
* ICH 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 and Data clarification forms as stipulated
* Manages multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
* Ensures quality of data submitted from study sites, collects data from sites within established timelines and ensures timely follow up/submission on any requested information
* Works across functions in the Company to ensure the readiness of supply kits for patient visits
* Ensures site compliance, safety and protection of study patients according to the clinical study plans, SOPs, and ICH and/or FDA GCP Guidelines. Works with site personnel/study team to prevent address and resolve issues
* Reviews adverse event reports (where required) and ensures site reporting of safety events in a timely manner
* Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner. Ability to track PD, subject visits, etc.
* Interacts and builds professional and collaborative relationships with all study personnel (study coordinator, investigator, pharmacist & cell therapy team members), peers and office-based personnel.
* Supervises overall activities of site personnel over whom there is no direct authority and motivates /influences them to meet study objectives. Provides full support to study sites to facilitate study conduct successfully
* Proactively communicates and escalates with all internal and external stakeholders any serious or outstanding issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.
* Ensures documented follow-up to all outstanding issues, within the scope of this position profile. Anticipates and proactively solves study site problems/issues as they occur. Initiates recommend and communicate corrective actions as needed
* Identifies, evaluates, and recommends potential investigators/sites on an ongoing to assist in the placement of planned clinical studies with qualified investigators.
* If required, prepares, coordinates and presents at Investigator Meetings and other study training
* Maintain up to date self-training e.g. ICH GCP and flag new/changes to site and clinical operations team
* Facilitates the Regulatory Compliance audit process, as needed.
* Provides monitoring assistance to site monitor colleagues, as requested, in addition to serving as a mentor to other colleagues as assigned.
* Available for travel up to 60% of the time, including overnight stays as necessary
* Any other ad-hoc tasks as required
* Responsible for adhering to all health and safety guidance, provided by the Company
* Uses multiple technologies to foster, maintain, and enhance open communication
* May be required to perform quality monitoring visits for sites currently monitored by contractors or CRO
* 3-5 years minimum monitoring experience, working as a CRA, in small pharmaceutical/biotech.
* 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
* Bachelors degree (BSc, BA or RN equivalent) in a biological or science-related field is essential
* A valid driving license.
* Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and service providers
* Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
* Excellent communication, interpersonal and organizational skills
* Effective problem-solving skills
* Attention to detail and meet specified timelines
* Computer literacy, proficiency in Microsoft Office.
* Preferably experienced with the use of eCRFs
* Ability to work independently and to effectively prioritize tasks
* Able to think ahead and anticipate needs before they arise
At Achilles, you will enjoy a flexible and dynamic working environment that fosters creativity, leadership and teamwork.
We offer benefits that include a competitive salary and performance-related bonus, an employee share incentive scheme and additional benefits.