FSP Sr Clinical Research Associate

Thermo Fisher Scientific•Wilmington, NC

About The Position

The Senior Clinical Research Associate performs and coordinates clinical monitoring and site management, conducting remote and on-site visits to assess protocol and regulatory compliance and managing required documentation. The role applies sponsor procedures and guidelines across monitoring environments and serves as a site-process specialist to help ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs; protect subjects’ rights and well-being; maintain reliable data; and remain audit-ready. The Senior CRA develops collaborative relationships with investigative sites and performs assigned tasks according to the study task matrix. The position monitors investigator sites using a risk-based approach, reviews data and investigational product, documents and escalates findings, and follows issues through to resolution. It supports site selection, initiation, conduct, and closeout, ensures essential documents are complete, and facilitates communication among sites, clients, and project teams. The role also maintains study systems and administrative records, contributes to project work and process improvement, and responds to audits and inspections. Travel is extensive, with a stated requirement of more than 75% and typical travel of 60–80%, potentially more, including overnight stays. The position is performed in office, laboratory, clinical, and/or home-office environments. Work may involve exposure to biological fluids and infectious organisms, electrical office equipment, and occasionally fluctuating or extreme temperatures. Required personal protective equipment may include protective eyewear, garments, and gloves. Physical demands include remaining upright or stationary for 6–8 hours per day, frequent mobility and computer use, repetitive hand movements, occasional crouching or stooping, frequent bending and twisting, and light-to-moderate lifting and carrying of objects up to 15–20 pounds. The role requires regular attendance, multitasking, and the ability to work under stress and adapt to changing demands.

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 2 years as a clinical research monitor, or other experience that provides the knowledge, skills, and abilities to perform the job.
Valid driver’s license where applicable.
Effective clinical monitoring skills.
Demonstrated understanding of medical or therapeutic-area knowledge and medical terminology.
Excellent understanding and demonstrated application of ICH-GCP, applicable regulations, and procedural documents.
Well-developed critical-thinking skills, including a 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, including the ability to communicate effectively with medical personnel.
Ability to maintain customer focus through listening skills, attention to detail, and recognition of customers’ underlying issues.
Effective interpersonal skills and strong attention to detail.
Effective organizational and time-management skills.
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, solid knowledge of Microsoft Office, and ability to learn appropriate software.
Good English language and grammar skills.
Good presentation skills.
Ability to travel frequently; the posting states a travel requirement of more than 75% and typical travel of 60–80%, with more travel for some individuals.
Ability to work upright or stationary for 6–8 hours per day; perform repetitive hand movements; maintain frequent mobility; occasionally crouch or stoop and frequently bend and twist the upper body and neck; and lift or carry objects up to 15–20 pounds.
Ability to use a variety of in-house and off-the-shelf computer software, communicate complex information, listen and understand spoken information, interact with diverse groups, multitask, work under stress, and adapt to variable demands.

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 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 in a timely manner using approved business writing standards.
Escalate deficiencies and issues to clinical management promptly and follow issues through to resolution.
Maintain contact between monitoring visits as needed to confirm protocol compliance, resolution of previously identified issues, 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) as required.
Update study systems according to agreed study conventions, including the Clinical Trial Management System (CTMS), and perform quality-control checks of CTMS reports where required.
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 ensure compliance with protocols, regulations, and ICH-GCP obligations; make recommendations where warranted.
Ensure trial closeout and retrieval of trial materials.
Ensure required essential documents are complete and in place according to ICH-GCP and applicable regulations.
Conduct on-site file reviews according to project specifications.
Assist with preparation of project publications and tools, and share ideas and 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 communication among investigative sites, the client company, and the PPD 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, on time.
Contribute to other project work and process-improvement initiatives as required.