Investigator Services Assistant - 2nd shift

Thermo Fisher Scientific • Covington, KY

1d • Onsite

About The Position

This is a fully onsite role based at our Global Central Labs in Highland Heights, KY. The Investigator Services Assistant provides support to most business units within the organization, working closely with investigator sites regarding data discrepancies and general study questions. The role supports the overall performance, education, and escalation of study questions or data discrepancies of the sites on a study level to ensure execution of protocols are completed accurately and on time. The assistant resolves issues during specimen accessioning, uses tools to ensure clean data, and places calls to investigator sites for sponsor alerts, voice alert values, and other critical values. Key daily activities include acting as the point of contact for sites and monitors via email or phone, monitoring, tracking, managing, and ensuring resolution of all complaints, discrepancies, and concerns, escalating to management/appropriate departments as needed. The role ensures communication with sites regarding protocol aspects, provides guidance on pre-analytical aspects, triages calls, reviews exceptions for data cleaning, resolves queries for timely sample analysis, and notifies sites of critical values. It also involves monitoring and escalating site issues, reviewing site performance metrics, evaluating requests for additional tests, coordinating and resolving issues with samples and requisition forms, amending patient information, attending study meetings, and working with the study PM team on requisition form creation.

Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years)
• Accurate data entry skills
• Intermediate computer skills including variety of computer software developed both in-house i.e. Microsoft Office
• Strong analytical, interpersonal and time management skills
• Strong client and phone service skills
• Basic knowledge of Good Clinical Practices and department principals such as pre-analytical technique, analytical and post-analytical influences on specimens and results
• Excellent verbal/writing communications and customer service skills in the English language
• Critical thinking and problem-solving skills to support quality decision making
• Good written and oral communication skills
• Ability to work in a collaborative team environment
• Ability to multitask
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
• Able to perform a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
• Must be legally authorized to work in the United States without sponsorship
• Must be able to pass a comprehensive background check, which includes a drug screening

Nice To Haves

• Additional languages

Responsibilities

• Provides support to most business units within the organization.
• Works closely with investigator sites regarding data discrepancies and or general study questions.
• Supports the overall performance, education, and escalation of study questions or data discrepancies of the sites on a study level.
• Helps ensure execution of protocols are completed accurately and on time.
• Resolves issues that arise during specimen accessioning to ensure specimen logging is accurate.
• Uses tools provided to answer questions and ensure clean data at the earliest point in time.
• Places calls to the investigator sites delivery sponsor alerts, voice alert values, and any other critical values.
• Acts as the point of contact for sites and monitors through email or phone.
• Monitors, tracks, manages, and ensures resolution of all complaints, discrepancies, concerns, and escalates to management/appropriate department to ensure satisfaction of internal and external customers.
• Ensures that the sites are communicated to regarding aspects of the protocol (following the study flow sheet) relating to the department.
• Provides guidance on pre-analytical aspects of the study to ensure smooth flow of data to and from the site.
• Triages calls where necessary to appropriate individual/departments and follow through to resolution.
• Continually reviews exceptions to resolve so that the data is cleaned within the agreed timelines.
• Resolves queries so that efficient and timely sample analysis is undertaken by the laboratory, so report turnaround time is met.
• Notifies the sites and all necessary contacts via telephone/email of all relevant critical/voice alert values/ study specific requirements.
• Monitors and escalates site issues through the appropriate departments/people e.g. project management to resolve and report as soon as possible.
• Ensures that all site issues are communicated and followed up to resolution, primarily to site and monitor.
• Reviews site performance metrics to educate where needed or to report back to monitor or sponsor.
• Follows the specifications and scope of work to evaluate requests for any additional test(s) (test performed in protocol) to be added to a sample.
• Evaluates the request for out of protocol testing following Scope of work for study.
• Facilitates requests to the appropriate person.
• Informs the investigator site of the results or reasoning not to proceed.
• Coordinates and resolves issues with samples and requisition forms at time of accessioning to have the samples and visit details in the database and reported as soon as possible.
• Amends patient information supplied by sponsors, project managers or investigator site into site database.
• Attends study meetings to discuss risk assessment for our department and or overall business concerns and reports back to the team about requirements.
• Works with study PM team on the creation of the requisition forms to ensure visit and study collection requirements are captured

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits
• Employment with an innovative, forward-thinking organization
• Outstanding career and development prospects
• Exciting company culture that stands for integrity, intensity, involvement, and innovation!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees