Clinical Project Specialist - Contract Position

The company 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 the company, 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.

HERE IS WHAT YOU WILL DO

• Document study plans for distribution to the team, sponsor, and the company 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 the company 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 the company 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, the company 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 [link for members]

The company is an equal opportunity employer. The company 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.