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

Thermo Fisher Scientific•Pittsburgh, PA

About The Position

The Clinical Research Associate II performs and coordinates all aspects of clinical monitoring and site management. The role conducts remote and on-site visits to assess protocol and regulatory compliance, manages required documentation, and applies procedures and guidelines across sponsor and monitoring environments. As a site-process specialist, the CRA ensures trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs to protect participant rights and well-being and ensure reliable data. The role also supports audit readiness and collaborative relationships with investigative sites. The position requires frequent travel to site locations, generally 60–80% and more for some individuals; the posting also lists a travel requirement greater than 75%. Work may be performed in an office, laboratory, clinical, or home-office environment and may involve extended overnight stays, exposure to biological fluids and infectious organisms, and use of personal protective equipment. The role has no management responsibility and reports progress updates to the Clinical Team Manager as required. The salary range listed for Pennsylvania is not provided. The position may be eligible for a variable annual bonus. U.S. benefits include national medical, dental, and vision plans; health incentive programs; employee assistance and family support programs; commuter benefits; tuition reimbursement; paid time off and holidays; paid parental leave; accident and life insurance; short- and long-term disability; a 401(k) retirement plan; and an employee stock purchase plan.

Requirements

Bachelor's degree in a life-sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
Experience comparable to at least 1 year as a clinical research monitor, or equivalent knowledge, skills, and abilities from relevant experience.
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.
Critical thinking skills, including a critical mindset, investigation for root cause analysis, 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 understanding customers' underlying issues.
Good organizational and time-management skills.
Effective interpersonal skills and attention to detail.
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 appropriate software.
Good English-language and grammar skills.
Good presentation skills.
Ability to work upright and/or stationary for 6–8 hours per day; frequent mobility; repetitive hand movements; occasional crouching or stooping and frequent bending and twisting of the upper body and neck.
Ability to lift or carry light-to-moderate objects, including luggage and a laptop, up to 15–20 pounds.
Ability to use varied computer software and communicate complex information, listen, and interact with diverse groups.
Ability to manage variable tasks and changing conditions, perform under stress, and multitask.
Ability to comply with sponsor, client, and site requirements, including requests for vaccination status or other personal information.

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 corrective or preventive actions.
Ensure data accuracy through source document review, source data verification, and case report form 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 follow issues through resolution.
Maintain contact with investigative sites between monitoring visits as needed to confirm protocol compliance, issue resolution, and timely data recording.
Conduct monitoring tasks according to the approved monitoring plan and 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.
Participate in investigator meetings as necessary.
Identify potential investigators with the client company and assess the acceptability of qualified investigative sites.
Initiate clinical trial sites according to relevant procedures and make recommendations 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 updates to the Clinical Team Manager as required.
Update study systems, such as the Clinical Trial Management System, according to agreed study conventions.
Facilitate communication among investigative sites, the client company, and the project team through written, oral, and electronic contacts.
Respond to company, client, and applicable regulatory requirements, audits, and inspections.
Complete administrative tasks, including expense reports and timesheets, in a timely manner.
Assist with 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%.
Meet the role's physical and attendance requirements, including regular attendance, multitasking, and working under stress.

Benefits

National medical and dental plans and a national vision plan, including health incentive programs.
Employee assistance and family support programs.
Commuter benefits.
Tuition reimbursement.
At least 120 hours of paid time off.
10 paid holidays annually.
Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
Accident and life insurance.
Short- and long-term disability in accordance with company policy.
Competitive 401(k) U.S. retirement savings plan.
Employee stock purchase plan 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.