Investigator Services Assistant

About the position

Responsibilities

• Provides support to most business units within the organization.
• Works closely with investigator sites regarding data discrepancies and general study questions.
• Supports the overall performance, education, and escalation of study questions or data discrepancies of the sites on a study level.
• Ensures 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.
• Ensures that the sites are communicated to regarding aspects of the protocol 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 follows through to resolution.
• Continually reviews exceptions to resolve so that the data is cleaned within the agreed timelines.
• Resolves queries to ensure efficient and timely sample analysis is undertaken by the laboratory.
• Notifies the sites and all necessary contacts of all relevant critical/voice alert values/study specific requirements.
• Monitors and escalates site issues through the appropriate departments/people to resolve and report as soon as possible.
• Ensures that all site issues are communicated and followed up to resolution.
• 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 tests to be added to a sample.
• Facilitates requests to the appropriate person and 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.
• Amends patient information supplied by sponsors, project managers or investigator site into site database.
• Attends study meetings to discuss risk assessment for the department 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.

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 with intermediate computer skills including a variety of computer software developed both in-house and Microsoft Office.
• Strong analytical, interpersonal, and time management skills.
• Strong client and phone service skills.
• Basic knowledge of Good Clinical Practices and department principles such as pre-analytical technique, analytical and post-analytical influences on specimens and results.
• Excellent verbal/written communications and customer service skills in the English language - additional languages are an advantage.
• Critical thinking and problem-solving skills to support quality decision making.
• Ability to work in a collaborative team environment.
• 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.
• Access to a retirement savings plan.
• Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year).
• Transit spending account.
• Paid sick leave under the applicable state or local plan.

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