Clinical Project Specialist - Contract Position

ProTrials Research, Inc.; Northern (KY); Hybrid; USD 65,000 - 95,000; Full time

Job summary

ProTrials Research, Inc. is a women-owned, WBENC-certified CRO seeking a Contract Clinical Project Specialist to oversee start-up through close-out of clinical trials, partnering with sponsors, sites, and cross-functional teams.

You will manage study plans, documents (Protocol, ICF, CRFs, TMF), TMF quality, and site activation, mentor CTA staff, and ensure regulatory compliance under ICH-GCP and FDA guidelines.

Qualifications

• 2-4 years of progressive experience as clinical research professional.
• Knowledge of FDA regulations and ICH-GCP Guidelines.
• Advanced proficiency in MS Office software (Word, Excel, PowerPoint).
• Proficiency in eTMF.

Responsibilities

• Document study plans for team, sponsor, and ProTrials management; review and update through the project life cycle.
• Develop and review study documents (Protocol, Investigator Brochure, ICF, CRFs, Operations Manual, study aids, site budget).
• Oversee and support feasibility via site capabilities information.
• Proactively manage essential study documents to obtain site activation.
• Lead start-up and site close-out activities; mentor CTA staff assisting with activations and closures.
• Participate in TMF QC activities and audits, ensuring inspection readiness and TMF quality.
• Schedule and attend team meetings; track action items and share status with sponsor and team.
• Provide status reports to sponsor, team, and ProTrials management; mass dissemination of documents.
• Keep leadership and CTA team updated on site and study status.
• Participate in outside vendors selection and management (CROs, labs, etc.).
• Ensure compliance with FDA, ICH-GCP, and SOPs.
• Support investigator screening and selection activities.
• Manage CTA resource planning, study organization, and data collection per project requirements.
• Mentor CTA team members and provide progress feedback.
• Update PM on progress, resources, sponsor issues, and performance.
• Ensure timely communication of sponsor requirements and changes.
• Review time codes and provide trends feedback to the project team.
• Review site invoices and payments.
• Contribute to Regulatory Authority Inspection Team and participate in inspections.

Skills

Team leadership

Coordination

Attention to detail

FDA regulations knowledge

ICH-GCP knowledge

MS Office (Word/Excel/PowerPoint)

eTMF proficiency

Tools

MS Office

eTMF

Job description

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.

Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health.

We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.

ABOUT THE JOB

The Contract Clinical Project Specialist plays a key role in the successful execution of clinical trials, partnering closely with project leadership, sponsors, sites, and cross-functional study teams from start-up through close-out. This position combines hands-on study coordination with project oversight, supporting study planning, site activation, TMF quality and inspection readiness, vendor management, and the tracking of critical project deliverables.

The ideal candidate is a proactive, highly organized clinical research professional who enjoys keeping complex studies moving forward, anticipating needs, and bringing teams together. You’ll have the opportunity to take ownership of important study activities, mentor CTA team members, collaborate directly with sponsors, and contribute to the quality and operational success of clinical trials.

HERE IS WHAT YOU WILL DO:

• Document study plans for distribution to the team, sponsor, and ProTrials management. Review and update study plans throughout the life of the project.
• Develop and/or review study documents, including Protocol, Investigator Brochure, ICF, CRFs, Operations Manual, study aids, and site budget
• Oversee and support the feasibility process via collection and review of site capabilities information
• Proactively manage, review, and approve essential study documents to obtain site activation
• Lead study start-up and site close-out activities, including strategic organization and execution of tasks, as well as lead and/or mentor staff assisting with site activations and site closures
• Participate in TMF QC activities and audits: supervise TMF activities, including coordination of inspection readiness, conduct, and oversee TMF quality control reviews according to study plans. Responsible for the quality of TMF deliverables
• Schedule and attend regular team meetings to track progress and status of team activities. May provide meeting agenda, transcribe or review meeting minutes, newsletters, mass site communications, and track action items to meet the specifications of the project team and sponsor
• Provide informal and formal status reports to sponsor, team, and ProTrials management. Prepare and provide mass dissemination of documents/information to include study sites
• Keep project leadership and CRA/CTA team fully apprised of site and study status
• Participate in the selection and management of outside vendors and their deliverables, such as CROs, DM groups, investigational product packaging, central laboratories, etc.
• Assure compliance with local regulations, Code of Federal Regulations/International Conference on Harmonization (ICH), Good Clinical Practices (GCP) guidelines, and ProTrials and sponsor SOPs
• Support activities related to investigator screening and selection
• Ensure CTA resource planning & resource management, study organization, tracking deliverables and out-of-scope, clinical supplies management, and data collection as needed occur within project requirements.
• Mentor CTA team members and monitor/guide progress by providing feedback and development around goals and deliverables for the assigned study
• Update PM on project progress, resource needs, sponsor issues, and team member performance
• Ensure timely and accurate communication of assigned aspects of the project to the team, including sponsor requirements, instructions and changes
• Run and review time code billing and provides feedback regarding trends and outliers to project team
• Provide review and tracking of site invoices and payments
• Contribute to the Regulatory Authority Inspection Team as reviewer, attend mock inspections/audits, and participate in regulatory inspection/audit as required

HERE IS WHAT YOU BRING TO THE TABLE:

• 2-4 years of progressive experience as clinical research professional
• Ability to lead and provide coordination and oversight of activities and team members, as needed
• Exceptional attention to details
• Knowledge of FDA regulations and ICH-GCP Guidelines
• Advanced proficiency in MS Office software, including Word, Excel, and PowerPoint are required
• Proficiency in eTMF

Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicant’s personal information in accordance with its statutory obligations and internal policies and procedures.

Information collected during application completion may be retained for a reasonable period of time and in accordance with the company’s established retention policies. Applicants seeking more information may contact [e-mail].

ProTrials is an equal opportunity employer. ProTrials is committed to providing a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration for employment without regard to race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.