FSP Sr CRA - Oncology OR Medical Device - Central US

Overview

Senior Clinical Research Associate (Level I/II) responsible for performing and coordinating all aspects of clinical monitoring and site management, conducting remote or on-site visits to assess protocol and regulatory compliance across FSP, FSO and government-sponsored studies.

What you'll do

• Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking and problem-solving to identify site process failures and corrective/preventive actions.
• Ensure data accuracy through SDR, SDV and CRF review during on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters in a timely manner using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• Maintain regular contact between monitoring visits to confirm protocol adherence, resolution of previously identified issues and timely data recording.
• Conduct monitoring tasks in accordance with the approved monitoring plan and participate in the investigator payment process.
• Share responsibility with other project team members for issues and findings resolution, and investigate and follow up on findings as applicable.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) and keep study systems such as CTMS updated per agreed study conventions, including QC checks of CTMS reports where required.
• Participate in investigator meetings as necessary.
• Identify potential investigators in collaboration with the client company to ensure acceptability of qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol, regulatory and ICH GCP obligations, making recommendations where warranted.
• Ensure trial close-out and retrieval of trial materials.
• Ensure required essential documents are complete and in place according to ICH-GCP and applicable regulations, and conduct on-site file reviews as per project specifications.
• Contribute to the project team by assisting in preparation of project publications and tools, and perform additional study tasks as assigned by the CTM.
• Facilitate effective communication between investigative sites, the client company and the project team through written, oral and/or electronic contacts.
• Respond to company, client and applicable regulatory requirements, audits and inspections.
• Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.
• Contribute to other project work and process improvement initiatives as required.

What you'll need

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent, and relevant formal academic or vocational qualification.
• Previous experience providing the knowledge, skills and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
• Valid driver's license where applicable.
• Multiple options available in either Medical Devices OR Oncology.
• Effective clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents.
• Well-developed critical thinking skills, including critical mindset, in-depth investigation for root cause analysis and problem solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Customer focus through good listening skills, attention to detail and the ability to perceive customers' underlying issues.
• Effective interpersonal skills.
• Strong attention to detail.
• Effective organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Ability to work in a team or independently as required.
• Good computer skills: proficient knowledge of Microsoft Office and ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.

Details

• Location: Remote, Indiana, USA.
• Work schedule: Standard (Mon-Fri).
• Work performed in an office, laboratory, clinical and/or home office environment with exposure to electrical office equipment.
• Frequent drives to site locations and frequent travel, generally 60-80% but more for some individuals, including possible extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms; personal protective equipment required (protective eyewear, garments and gloves).
• Exposure to fluctuating and/or extreme temperatures on rare occasions.
• Must comply with specific sponsor, client or site requirements even where not required by Thermo Fisher Scientific (e.g., disclosure of vaccination status or other personal information), which may need to be provided directly to the sponsor, client or site.