FSP Experienced Clinical Research Associate (CRA II/Sr. CRA I) - Oncology - Respiratory - Cardiovascular - US Southeast (Open)

Thermo Fisher Scientific • Wilmington, SC

5d • $105,000 - $112,000

About The Position

Performs and coordinates clinical monitoring and site management for oncology, respiratory, and cardiovascular studies in the U.S. Southeast. Conducts remote and on-site visits to assess protocol and regulatory compliance, manages required documentation, and applies sponsor and monitoring-environment procedures. Acts as a site-process specialist to help ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs, protecting participant rights and well-being and supporting data reliability and audit readiness. Develops collaborative relationships with investigational sites. The role involves frequent travel, generally 60–80%, with the posting also stating a travel requirement greater than 75%; extended overnight stays may be required.

The position monitors sites using a risk-based approach, evaluates data and investigational product, documents and escalates issues, and follows findings through resolution. It supports site selection, initiation, ongoing oversight, and closeout; maintains essential documents and study systems; and communicates with sites, clients, and the project team. The role also contributes to project tasks and process-improvement initiatives, and responds to audits and inspections.

The role requires a bachelor's degree in a life-sciences-related field, registered nursing certification, or equivalent relevant qualification, as well as experience comparable to 1–5 years as a clinical research monitor, depending on level. The position has no management responsibility. Work may take place in an office, laboratory, clinical, or home-office environment, with frequent driving to sites and exposure to biological fluids and potentially infectious organisms. Protective equipment may be required.

Requirements

• Bachelor's degree in a life-sciences-related field, registered nursing certification, or equivalent relevant formal academic or vocational qualification.
• Experience providing the knowledge and skills to perform the role, comparable to 1–5 years as a clinical research monitor depending on the level.
• Valid driver's license where applicable.
• Effective clinical monitoring skills.
• Understanding of medical or therapeutic-area knowledge and medical terminology.
• Strong understanding and demonstrated application of ICH-GCP, applicable regulations, and procedural documents.
• Critical-thinking skills, including a critical mindset, in-depth investigation, root cause analysis, and problem-solving.
• Ability to manage risk-based monitoring concepts and processes.
• Effective oral and written communication skills, including communicating with medical personnel.
• Ability to maintain customer focus through listening, attention to detail, and identifying customers' underlying issues.
• Effective interpersonal skills and strong attention to detail.
• Effective organizational and time-management skills.
• Flexibility and adaptability across a wide range of scenarios.
• Ability to work independently or as part of a team.
• Good computer skills, including solid knowledge of Microsoft Office and ability to learn relevant software.
• Good English-language and grammar skills.
• Good presentation skills.
• Ability to comply with sponsor, client, or site requirements, which may include disclosing vaccination status or other personal information.
• Ability to work upright or stationary for 6–8 hours per day; make repetitive hand movements; travel frequently and drive to sites; occasionally crouch or stoop and frequently bend or twist the upper body and neck; and lift or carry objects such as luggage and a laptop weighing up to 15–20 pounds.
• Ability to use computer software, communicate and understand complex information, interact with diverse groups, handle variable tasks and changing conditions, perform under stress, and multitask.

Responsibilities

• Monitor investigator sites using a risk-based monitoring approach.
• Apply root cause analysis, critical thinking, and problem-solving to identify site-process failures and define corrective and preventive actions.
• Ensure data accuracy through source document review (SDR), source data verification (SDV), and case report form (CRF) review, as applicable.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters promptly and according to approved business-writing standards.
• Escalate deficiencies and issues to clinical management and follow them through resolution.
• Maintain contact with investigational sites between monitoring visits as needed to verify protocol compliance, issue resolution, and timely data recording.
• Conduct monitoring tasks according to the approved monitoring plan.
• Participate in the investigator payment process.
• Share responsibility with project team members for resolving issues and findings; investigate and follow up on findings as applicable.
• Provide trial-status tracking and progress updates to the Clinical Team Manager (CTM).
• Update study systems according to agreed study conventions, including the Clinical Trial Management System (CTMS), and perform quality-control checks of CTMS reports when required.
• Participate in investigator meetings as necessary.
• Identify potential investigators with the client company and assess the acceptability of qualified sites.
• Initiate clinical trial sites according to relevant procedures and compliance obligations, making recommendations where warranted.
• Ensure trial closeout and retrieval of trial materials.
• Ensure essential documents are complete and in place according to ICH-GCP and applicable regulations; conduct on-site file reviews as specified by the project.
• Contribute to project publications and tools and share suggestions with team members.
• Perform additional study tasks assigned by the CTM, such as trip-report review, newsletter creation, or leading CRA team calls.
• Facilitate written, oral, and electronic communication among investigational sites, the client company, and the PPD project team.
• Respond to company, client, and applicable regulatory requirements, audits, and inspections.
• Complete administrative tasks, including expense reports and timesheets, promptly.
• Contribute to other project work and process-improvement initiatives as required.

Benefits

• Choice of national medical and dental plans and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off and 10 paid holidays annually.
• Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance, and short- and long-term disability, in accordance with company policy.
• Competitive 401(k) U.S. retirement savings plan.
• Employees' Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount.
• The position may be eligible for a variable annual bonus based on company, team, and/or individual performance results, in accordance with company policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level