Study Start up Specialist

 

Position Overview

The role of the Study Start-up Specialist is to coordinate start-up activities for multiple research sites within AMR. This role is responsible for ensuring complete and accurate performance of study start-up activities in compliance with the Food and Drug Administration (FDA) regulations.

To consistently embody AMR’s Core Values:

· Excellence and Consistency

· Collaborative Innovation

· Respect for our Subjects, Sponsors and Team Members

· Community

· Unimpeachable Ethics

The Study Start-up Specialist reports to the Study Start-Up Manager and Director of Project Manager.

Classification: Non-Exempt

Primary Responsibilities include but not limited to:

· Navigate the study from award to greenlight for enrollment as quickly and efficiently as possible; while preparing the site to screen its first subject with the minimum number of days between greenlight for enrollment and the first screened subject (Goal: 1 day).

· Advanced understanding of all upcoming studies.

· Main point of contact, for assigned sites, during study start-up. Communicates with site’s assigned CRA, other CRO/Sponsor delegate, regarding information such as study timelines, sponsor required training, pending supplies, required vendor access, etc.

· Completes and/or tracks completion, as applicable, start-up documents e.g., contact forms, access request forms, etc.

· Tracks completion of training of applicable study specific training and ensures completion within a timely manner.

· Maintain Study Launch Dashboard to track start-up progress to ensure sponsor/CRO timeline expectations are met e.g., training completion, vendor(s), supplies, and investigational product receipt, etc.

· Consistently communicates with site staff on study supplies needs e.g., lab supplies, diaries, thermometers, subject cards, etc.

· Ensure delegation logs are complete prior to greenlight for enrollment.

· Works with Study Start-Up Manager and Project Manager on special projects when needed.

· Conduct, at minimum, monthly calls with assigned AMR sites. This can be with site CRCs and/or site managers.

· Track start-up metrics for all studies at assigned AMR sites. These include

o Award date

o SIV date

o Greenlight Activation Date

· Other duties as assigned

Desired Skills and Qualifications:

• One year of experience in a clinical research field.
• Strong understanding and adherence to standard operating procedures, regulatory, FDA regulations, and GCP and ICH guidelines.
• Thoroughness and Accuracy: Able to collect, organize, interpret, and record information as required by study sponsors and regulatory agencies.
• Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing circumstances).
• Metric driven with strong written and verbal communication skills among sponsors, CROs, vendors, AMR site staff and team members.
• Independence: Demonstrates the ability to act independently, initiating activity as required and makes appropriate decisions within the constraints of this job description and company policies and procedures.
• Adaptability: Able to initiate or modify behavior to accomplish tasks despite environmental factors, priorities, or problems that might not be well defined or that are subject to change. Understands nature and intent of instructions and masters new routines or task quickly.
• Computer Skills: Able to use standard office software, as well as proprietary applications unique to the clinical research industry and individual sponsoring organizations.
• Work Hours: 40 hours a week, Monday – Friday. Work can include “non-standard” hours.
• Typical Mental Demands: Required to manage multiple tasks and adhere to strict study protocol and regulatory and compliance requirements and company standard operating procedures and policies.

Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.

** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.

Job Type: Full-time

Pay: From $20.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• Clinical research: 1 year (Required)
• Data entry: 1 year (Required)

Work Location: Remote

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