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Senior Clinical Research Associate, Early Phase

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Company :
Achilles Therapeutics

Location :
Philadelphia, Pennsylvania

Expiry Date :
Wed, 07 Jul 2021 23:59:59 GMT

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Description :
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.

Role Summary:

The Senior Clinical Research Associate (SCRA) supports successful execution and timely completion of Achilles clinical studies by monitoring and/or supervising monitoring activities to ensure data integrity and compliance with the FDA regulations, ICH-GCP guidelines and SOPs.

The ideal candidate has extensive experience in clinical study execution, including monitoring oncology and cell therapy studies. You must have progressed from a Field monitor to managing CRAs from both line management and functional management.

Key Responsibilities_._

* Assist in the preparation of clinical study documentation such as study protocols
* Informed Consent Forms (ICFs), study-specific plans, manuals, Case Report Forms (CRFs), training materials, CRF completion guideline as well as User Acceptance Test (UAT) of the EDC system for each study
* Review workload requirements and provides resources for all clinical field activities.
* Ensure the direct reports perform their duties in line with the code of Federal Regulations (CFR) of Food and Drug Administration (FDA) and the ICH guidelines, SOP
* Develop a Monitoring Plan for each clinical trial.
* Train monitors (CRAs) and other clinical trial support staff (CTAs).
* Ensure monitors have adequate training to perform their role. Including Site qualification visits, Initiation, Interim monitoring and site close-out visits.
* Oversee site activation process for each study
* Develop and monitor metrics to evaluate the monitor and site performance. In the event of performance concerns, evaluate the cause and risk mitigation of a study.
* Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring
* Track patient enrollment and recommend solutions to monitoring staff to increase appropriate enrollment of qualified subjects
* Provide support for the processing of data queries
* Review and approve monitoring visit reports, confirmation letters and follow-up letters
* Support in review of protocols
* Review site-level ICF and site-related material
* Co-Monitor as required to provide coaching and manage the performance of CRAs
* May be required to generate study documents such as monitoring report templates, monitoring manual, study operations manual, source data verification plan, laboratory manual, ICF.
* Contribute and/or review CRF completion guideline
* Experience and responsible for some TMF tasks (Veeva preferable)
* Plan and participate in Investigator meetings
* Liaise with doctors/Investigators and other site staff as well as vendors (e.g. CRO, Lab, Imaging)
* Support identification, requirements and evaluation of clinical study sites.
* Ensure that the Project Manager / Clinical Operations Manager and other team members are aware of all monitoring metrics and critical issues.
* Being a key representative for monitoring responsibilities and assists assigned study monitors in maintaining relationships and rapport with clinical investigational site personnel.
* Participate in CRA project-specific training
* Assist Project Manager and Quality team to ensure the quality of field monitoring by conducting co- monitoring visits and performance assessment visits with Site Monitors
* Provide a key role in problem-solving and issue escalation
* Mentor and co-monitors with CRAs on assigned teams
* May be responsible for a geographic area and travel, as required by study, needs to conduct site initiation visits, interim monitor visits, close-out visits, or unblinded monitoring visits
* Focus on meeting enrollment timelines and developing subject recruitment strategies
* Participate in clinical trials Bid Defenses with Vendors and may be required to give input of RFPs.
* Miscellaneous duties, as necessary, in support of Clinical Monitoring initiatives
* Support the sites and CRA for inspection readiness, as well as internal inspection readiness

Requirements

* 10 years experience in clinical monitoring and site management
* Field monitoring experience in early phase Oncology is mandatory
* Strong data and site management experience
* Cell therapy experience is a plus
* Experience in performing inspection readiness activities
* Biotech and Pharma industry background.

Qualifications

* Bachelors degree (BSc, BA or RN equivalent) in a biological or science-related field is essential
* A valid driving license.

Skills/Specialist knowledge

* 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
* Excellent oral and written communication, organizational and planning skills
* Thoroughness and dealing with complexity
* Willingness to travel as needed

Benefits

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.