Clinical Research Associate Trainee (Spain)

Who We Are Celebrating 40+ years!

Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service based company we support both domestic and international sponsors in the conduct of both early and late phase trials.

As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will the work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

What You'll Do Hiring a Full time Permanent CRA (Trainee) in Spain (Home Based).

The CRA trainee program offers talented applicants an entrance ticket to many career pathways within the pharmaceutical industry. Theradex Oncology is a full-service Contract Research Organization (CRO). Theradex assist the pharmaceutical industry with the complete set of services that is required to bring a product from first-in-man to market registration. Talented candidates are able to reach the Senior CRA position from the CRA trainee program. Other career pathways may subsequently be available within the full service offering to our clients. We encourage applications by multilanguage applicants. This role requires fluency in Spanish, English language and a second European language is advantageous.

The primary responsibilities of this position include, but are not limited to, the following :

Complete all company specific trainings timely once assigned.

Successful completion of provided CRA Trainee course within 6 months of employment start.

Act as administrative support to PMs, CRAs and functional area leads during CRA Trainee period.

Assist in the day to day running of projects assigned.

Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.

Participate in project administration as required e.g., photocopying, binder preparation, start-up pack preparation etc.

Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice.

Work in collaboration with on-site CRAs to meet Sponsor, Protocol and Theradex objectives of Regulatory Readiness including contract and budget negotiations, as required.

Assist on routine communications with study sites, providing study updates and support to sites and providing project team updates on site related issues.Ensure site communications are documented and archived as per project requirements and Theradex Oncology SOPs.

Responsible for assisting in the preparation of the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies. Assist study staff with maintaining the sponsor files during the life of the study.

Assist in archiving at the end of study in accordance with relevant SOPs, policies and local regulatory.

Maintain / up-date site information (including all contact details, contracts, and reports).

Performs ongoing management of essential regulatory documentation at the outset and across the lifespan of a study, such as : Essential document collection, review, upload, maintenance, and close-out activities, ensuring that that sponsor and investigator obligations are being met and follow applicable local regulatory requirements and ICH / GCP guidelines.

Perform Site Essential Documentation verification prior to upload into the eTMF.

Performs quarterly QC of each study in the eTMF according to Theradex Oncology SOP.

Performs study tracking via CTMS, investigator site file tracker (if utilized) and / or sponsor designated system to ensure that the study files are current, accurate and complete.

Ensures protection of subjects, subjects' rights, and the integrity of data through adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures, and protocol compliance.

Assist in the conduct of pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits in accordance with the relevant SOPs to include but not limited to : Source document review and comparison to CRF data

CRF review / retrieval and data corrections

IMP accountability

Maintenance of on-site investigator files

IEC / IRB documentation

Local laboratory documentation

Maintenance of investigational supplies

Subject consent and consent process review (Informed Consent Form and source documentation)

Verify patient eligibility

Assess protocol compliance and deviations

Handling of safety and efficacy issues, including, but not limited to : Serious adverse event reports

Adverse event trends

Treatment failures

Assist with site visit report preparation within study specific timeframe

Assist with all aspects of site management as described in the study plans

Proactively identify and resolve potential site and study issues.

Identify and escalate data quality issues to ensure clinical data integrity

Provide support to project management via ongoing project reports and updates.

May be responsible for supporting multiple studies simultaneously Must prioritize appropriately to meet business needs to ensure on-time, quality deliverables.

Perform other duties as assigned by management.

What You Need Level of Education

At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or human science-related field or equivalent experience.

Oncology knowledge / PhD preferred

Prior Experience

Previous experience with Clinical Research Site Coordination or related fields (i.e. Regulatory Specialist) preferred.

Previous experience in monitoring (i.e. In-House CRA / CTA / CMA) or equivalent experience) preferred.

Study Start up experience is an advantage

Skills and Competencies

Professional attitude with good customer focus.

Strong communication skills : verbal / written / presentation.

Good interpersonal skills, including persuasion and influence.

Able to work independently as well as in a group.

Good time management, multitasking and execution skills.

Good organizational skills, including efficiency, punctuality, and collaboration in a team environment.

Demonstrated proficiency in Microsoft Outlook, Word, and Excel.

Technically proficient enough to work in a remote environment and able to address minor technical challenges without support but will timely escalate to Information

Technology Support for challenges beyond capabilities.

Capable of absorbing and applying knowledge gained through internal and external trainings on protocols assigned.

Knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.

Effective knowledge of the drug development process and the Theradex organizational structure

Additional Requirements

This position involves international and / or national travel as needed to meet study requirements. Ability to travel domestically and / or internationally and may involve overnight stays. Travel requirements are up to 70%.

Valid Driver’s License preferable.

Passport essential

Successfully pass background clearance checks which may be run on a periodic basis due to 3rd party contractual obligation requirements.

Fluent in English, Spanish and another European language is an advantage.

What we offer :

We offer a friendly and supportive culture that puts people first.

Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.

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