Clinical Trial Coordinator - Regulatory - Remote US

Fortrea; Durham (NC); Remote; USD 65,000 - 75,000; Full time

Job summary

Fortrea is seeking a Clinical Trial Coordinator - Regulatory for a Remote US role. You will act as the liaison for the project team and investigative sites, coordinating contacts, reports, and study activities according to protocol.

Responsibilities include site monitoring, assisting CRAs with visits, Case Report Form reviews, and CTMS data entry. You will support regulatory submissions and translations as regionally required.

Qualifications

• At least one year of experience in a related field (medical, clinical, pharmaceutical, data management, etc.).
• 1–2 years of clinical research experience is required.
• Basic understanding of biology and biological processes.
• Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP.
• Good organizational and time management skills; strong written and oral communication.
• General computer literacy and ability to work in a matrix environment.

Responsibilities

• Serve as contact for project team and investigative sites, document contacts and contact reports per study guidelines.
• Monitor site performance and implement action plans with the CRA as needed.
• Assist CRAs with site visits preparation, reports, file QC and action item resolution.
• Perform Case Report Form reviews and query resolution under supervision.
• Coordinate study visits and shipment of drug, supplies, and lab kits.
• Manage sites to ensure subject compliance with protocol, visits and timelines.
• Distribute and track clinical trial materials to sites and monitor supply levels.
• Ensure amendments and revised documents are completed for assigned sites as applicable.
• Enter weekly details in CTMS and use trial management tools as required.
• Support submissions and notifications to Ethics Committees and Regulatory Authorities; translate documents when needed.

Skills

Clinical research

Documentation

Organization

Communication skills

Computer literacy

Time management

Education

Bachelors degree in life sciences or related field

Certification in allied health profession

Tools

CTMS

Data management systems

Job description

Fortrea's FSP team is hiring a Clinical Trial Coordinator- Regulatory - Remote US

Job Overview:

We are seeking a Clinical Trial Coordinator - Regulatoryto serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites asrequiredper study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.

Responsibilities:

• Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites asrequiredper study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.

• Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.

• Assist CRAs with preparation for site visits (i.e.running reports, QC of files (checking for missing documents), resolving action items frompreviousvisits).

• Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Fortrea or client data management systems, as assigned by management.

• Assistwith the coordination of study visits and shipment of drug, ancillarysuppliesand laboratory kits/samples.

• Manage sites to ensure subjects arecomplying withprotocol requirements, study visits, and timelines.

• Liaise with the project team and others to distribute and track clinical trial supplies,e.g.Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.

• Proactively work with sites and project teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.

• Demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate withinthe differentsections. To enter weekly details in CTMS or as per study requirement.

• Assistin submissions and notifications to Ethics Committees and Regulatory Authorities as applicable inregion.

• Facilitate translation and back translation of all necessary documents asappropriate forlocal country requirements and as needed regionally.

• Attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) andto presentat the meetings.

Requirements:

• At least one year of experience in a relatedfield, (e.g.medical, clinical, pharmaceutical, laboratory research, data analysis, datamanagementor technical writing).

• 1-2 years of clinical research isrequired.

• Basic understanding of biology and biological processes

• Ability tomonitorstudy sites according to protocol monitoring guidelines, SOPs, ICHGuidelinesand GCP.

• Good organizational and time management skills

• Good communicationskills, oral andwritten

• Exhibitsgeneral computerliteracy

• Works efficiently and effectively in a matrixenvironment

Qualifications (Minimum Required):

• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Physical Requirementsts:

• Ability to sit for extended periods and operate a vehicle safely.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Regular and consistent attendance.

• Varied hours may be required.

• Target Pay Range: $65-75K

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