FSP Sr. CRA (Oncology & Cell Therapy)

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as an FSP CRA – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Senior Clinical Research Associate (Level I), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. What You’ll Do: • Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process gaps and implement appropriate corrective and preventive actions (CAPA). • Perform on-site and remote monitoring activities, including SDR, SDV, CRF review, and investigational product accountability, to ensure protocol compliance, subject safety, and data integrity. • Prepare monitoring reports, follow-up letters, and other study documentation in a timely manner using approved business writing standards. Escalate site issues and follow them through to resolution in collaboration with clinical management and the project team. • Maintain regular communication with investigative sites between monitoring visits to ensure protocol adherence, timely data entry, and resolution of outstanding issues. • Support investigator payment activities and contribute to the timely resolution of monitoring findings in partnership with cross-functional project team members. • Participate in investigator meetings and support site identification, qualification, initiation, and close-out activities in accordance with study requirements, applicable regulations, and ICH-GCP. • Ensure essential documents are complete, accurate, and maintained in accordance with ICH-GCP, applicable regulations, and project requirements. Conduct on-site file reviews as specified by the study. • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required. • Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc). • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. • Responds to company, client and applicable regulatory requirements/audits/inspections. • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. • Contributes to other project work and initiatives for process improvement, as required. • The role may involve a broader mix of clinical operations and project support activities to meet study and business needs. Candidates who are adaptable, collaborative, and willing to take on a variety of responsibilities while developing within the role will be well suited for this position. Leveling will be determined based on the candidate's experience, demonstrated competencies, and ability to independently manage clinical trial activities. For Senior CRA: In addition to the responsibilities above, this role is expected to manage more complex studies and sites, proactively lead risk identification and mitigation, mentor less experienced CRAs, and serve as a key operational partner to the project team. Education and Experience Requirements: • Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor). • Valid driver's license where applicable • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • 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 but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving • Ability to manages Risk Based Monitoring concepts and processes • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel • Ability to maintain customer focus through the utilization of good listening skills, attention to detailand 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 the ability to learn appropriate software • Good English language and grammar skills • Good presentation skills Working Conditions and Environment: • Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. • Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. • May also include extended overnight stays. • Exposure to biological fluids with potential exposure to infectious organisms. • Personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions. • Must be able to comply with specific sponsor/client/site requirements, even if not required by Thermo Fisher Scientific (e.g., disclosure of vaccination status, or other personal information). On some occasions, this information may be required to be provided directly to sponsor/client/site.