Investigator Services Assistant

About the position

The Investigator Services Assistant plays a crucial role in supporting various business units within the organization by managing data discrepancies and ensuring the smooth execution of clinical study protocols. This position requires strong data entry skills, excellent communication abilities, and a background in clinical research or related fields. The role involves working closely with investigator sites, resolving issues, and ensuring accurate data management to facilitate timely sample analysis and reporting.

Responsibilities

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

Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
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• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
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• Accurate data entry skills with intermediate computer skills including a variety of computer software developed both in-house and Microsoft Office.
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• Strong analytical, interpersonal, and time management skills.
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• Strong client and phone service skills.
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• Basic knowledge of Good Clinical Practices and department principles such as pre-analytical technique, analytical and post-analytical influences on specimens and results.
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• Excellent verbal/written communications and customer service skills in the English language - additional languages are an advantage.
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• Critical thinking and problem-solving skills to support quality decision making.
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• Ability to work in a collaborative team environment.
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• Ability to multitask and perform successfully under pressure while prioritizing and handling multiple projects or activities.

Nice-to-haves

• Additional languages are an advantage.

Benefits

• Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.
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• Access to a retirement savings plan.
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• Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year).
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• Transit spending account.
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• Paid sick leave under the applicable state or local plan.

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