Job Description

Senior Clinical Research Associate: * * Oncology

Kelly Science and Clinical is excited to partner with a dynamic mid-size CRO to hire Senior Clinical Research Associates (CRAs) specializing in oncology. We are seeking candidates with current or recent experience in oncology monitoring, you will have the opportunity to work in other therapeutic areas. Preference will be given to those within commuting distance to major airports and with proven oncology experience. Travel requirements can be up to 80% at times, with scheduling based on time zones to the extent possible. If you have a solid track record in monitoring that demonstrates consistent career growth, we want connect with you to see if this opportunity will be your next home!

Job Duties and Responsibilities:

The Sr CRA will build, manage, and support site relationships while serving as liaison between the Sponsor and assigned sites. The Senior Clinical Research Associate I with monitor investigational sites to ensure subject safety and provides high quality data review and reporting in compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, ISO14155, and other applicable regulations.

• Serves as primary contact for assigned research sites.

• Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.

• Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.

• Ensures assigned sites are conducting studies according to protocol requirements or investigational plan and applicable regulations and guidelines.

• Verifies that the rights and well-being of trial subjects are protected.

• Reconciles site regulatory binder assuring collection and completeness of regulatory documents.

• Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.

• May support translations of essential documents

• May support submission of trials to IRB/IEC and regulatory authorities.

• Verifies that written informed consent was obtained before each subject’s participation in the trial.

• Verifies that the investigator is enrolling only eligible subjects.

• Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan. Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.

• Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.

• Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.

• Verifies and supports the recording and reporting of adverse events/serious adverse events. Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.

• Ensures that sites have sufficient project specific supplies.

• Manages investigative sites in respect to the trial conduct and motivates sites to meet study goals.

• Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.

• Delivers quality written trip reports, confirmation, and follow-up letters within timelines of SOPs and Monitoring Plans.

• Attends and participates in team teleconferences and training.

• Participates in relevant trial meetings, e.g., Kick off, Investigator, and Monitor meetings.

• Participates in site audits, as requested.

• May conduct site and study feasibility assessments.

• May be involved in the development of monitoring guideline and tools.

• Provides input into study documentation and monitoring worksheets.

• Uphold the confidentiality agreements with all clients and colleagues outside Caidya.

• Pays attention to signals of fraud, misconduct and escalates per Caidya SOP.

• Work according to the Caidya Quality Management System and actively participate in giving feedback and suggesting improvements to current processes.

• Work according to the project-specific timelines and budget agreement, which has been agreed upon with the sponsor. Accurately document the time spent per project in the Caidya time allocation system.

• Demonstrates flexibility and adaptability.

• Proactively identifies, manages, escalates (as needed), and resolves site issues effectively and independently.

• Other duties as assigned by Clinical Operations Manager/Project Manager and per project-specific requirements.

• May participate in delivering Clinical Monitoring portion of a bid defense presentation.

• Provides support to Project Team and Clinical Operations Team.

• Maintains working knowledge of protocols and Monitoring Plans for assigned projects.

• Demonstrates strong written and verbal communication skills.

Job Requirements:

Education

• 4-year college graduate, preferably with a healthcare or life science degree.

Experience

• Minimum of 3 years of experience in on- site monitoring clinical studies.

• Oncology monitoring or clinical research experience - recent or current oncology needed

• Ability to drive an automobile and have a valid driver’s license, if applicable.

• Valid passport required in the case of international business travel.

• Ability to travel up to 80%.

• Strong written and verbal communication skills and interpersonal skills.

• Strong monitoring skills to independently conduct all types of site monitoring visits.

• Proficient computer skills, including Microsoft Office, EDC, and CTMS systems.

• Comprehensive knowledge of GCP/ICH guidelines.

• Proficiency in medical terminology.

• Able to exercise judgment within defined procedures and practices and to determine. appropriate action independently.

• Attention to detail and problem-solving skills.

• Ability to work in a matrix environment with strong time management and organizational skills.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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