FSP Clinical Research Associate II - U.S. Northeast Region - Multiple Therapies

Thermo Fisher Scientific • Pittsburgh, MA

7d

About The Position

The Clinical Research Associate II performs and coordinates clinical monitoring and site management activities, including remote and on-site visits to assess protocol and regulatory compliance and manage required documentation. The role applies sponsor-specific procedures and guidelines and serves as a site-process specialist, supporting conduct of trials in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs to protect subjects and ensure reliable data and audit readiness. The CRA develops collaborative relationships with investigational sites. Travel is generally 60–80%, with the role description also stating a travel requirement greater than 75%; extended overnight stays may be included.

The position works on problems of moderate scope, ordinarily receives general instructions for routine work and detailed instructions for new projects, and exercises judgment within defined procedures. It has no management responsibility. The work may be performed in an office, laboratory, clinical, or home-office environment, with frequent driving to site locations and possible exposure to biological fluids and infectious organisms. Required personal protective equipment may include protective eyewear, garments, and gloves.

Requirements

• Bachelor's degree in a life sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
• Experience providing knowledge, skills, and abilities comparable to at least 1 year as a clinical research monitor.
• Valid driver's license where applicable.
• Proven clinical monitoring skills.
• Understanding of medical or therapeutic-area knowledge and medical terminology.
• Ability to attain and maintain working knowledge of ICH-GCP, applicable regulations, and procedural documents.
• Well-developed critical-thinking skills, including a critical mindset, in-depth root-cause investigation, and problem-solving.
• Ability to manage risk-based monitoring concepts and processes.
• Good oral and written communication skills, including effective communication with medical personnel.
• Ability to maintain customer focus through listening, attention to detail, and recognition of underlying customer issues.
• Good organizational and time-management skills.
• Effective interpersonal skills and attention to detail.
• Ability to remain flexible and adaptable across a wide range of scenarios.
• Ability to work independently or as part of a team, as required.
• Good computer skills, including solid knowledge of Microsoft Office and ability to learn appropriate software.
• Good English-language and grammar skills.
• Good presentation skills.
• Ability to comply with sponsor, client, or site requirements, which may include disclosure of vaccination status or other personal information.
• Ability to work upright and/or stationary for 6–8 hours per day; perform repetitive hand movements; maintain frequent mobility; 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, manage variable tasks and changing conditions, perform under stress, multitask, and maintain regular and consistent attendance.

Responsibilities

• Monitor investigator sites using a risk-based monitoring approach.
• Use root cause analysis, critical thinking, and problem-solving to identify site-process failures and develop corrective or preventive actions.
• Ensure data accuracy through source document review (SDR), source data verification (SDV), and case report form (CRF) review, as applicable, during on-site and remote monitoring.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters promptly using approved business-writing standards; escalate deficiencies and issues and follow them through resolution.
• Maintain contact with investigative sites between visits as needed to confirm protocol compliance, resolution of identified issues, and timely data recording.
• Conduct monitoring tasks according to the approved monitoring plan and participate in investigator payments.
• Share responsibility with project team members for resolving issues and findings; investigate and follow up on findings as applicable.
• Participate in investigator meetings as necessary.
• Identify potential investigators with the client company and help assess the suitability of qualified investigative sites.
• Initiate clinical trial sites according to applicable procedures and recommend actions to support protocol, regulatory, and ICH-GCP compliance.
• Perform trial closeout and retrieve trial materials.
• Ensure essential documents are complete and in place according to ICH-GCP and applicable regulations.
• Conduct on-site file reviews according to project specifications.
• Provide trial-status tracking and progress reports to the Clinical Team Manager as required.
• Update study systems, such as the Clinical Trial Management System (CTMS), according to agreed study conventions.
• Facilitate written, oral, and electronic communication among investigative sites, the client company, and the project team.
• Respond to company, client, and applicable regulatory requirements, audits, and inspections.
• Complete administrative tasks, including expense reports and timesheets, promptly.
• Assist with preparation of project publications and tools, share suggestions with team members, and contribute to other project work and process-improvement initiatives as required.
• Travel frequently to site locations; the posting specifies a travel requirement greater than 75% and also describes travel as generally 60–80%, potentially more, with possible extended overnight stays.

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 (PTO) and 10 paid holidays annually.
• Paid parental leave, including 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.
• Employee Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount.
• Potential eligibility for a variable annual bonus based on company, team, and/or individual performance.

What This Job Offers

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