Massachusetts Veterans Jobs

Job Title: Clinical Research Coordinator

Job Description

We are seeking a Clinical Research Coordinator to oversee the day-to-day operations of clinical trial activities at site-level locations. This role involves direct interactions with study participants, managing study protocols, and ensuring compliance with regulatory requirements. The position requires a dedicated individual who can work on-site 5 days a week at various pharmacy locations.

Responsibilities

• Manage and oversee the administration of clinical trial activities at the site-level.

• Interface with current and potential clinical trial participants to determine eligibility and obtain consent.

• Create standard operating procedures (SOPs) adhering to FDA and OHRP regulations.

• Contribute to the training of clinical trial staff and ensure compliance with operational requirements.

• Serve as the primary point of contact for participants, keeping them informed about study progress.

• Schedule participant visits and troubleshoot technical issues, escalating as necessary.

• Solicit and record safety event information and prepare documentation for Principal Investigator review.

• Provide accurate and timely data collection, documentation, entry, and reporting.

• Support regulatory staff in maintaining regulatory documents in accordance with SOPs and applicable regulations.

• Communicate and collaborate study requirements with the research team, sponsors, monitors, PI, and participants.

• Maintain regular contact with the Principal Investigator and team to review study details.

• Maintain study supplies and issue participant stipends.

• Ensure appropriate credentialing and training of the study team.

• Facilitate meetings with study monitors, auditors, and investigators.

• Ensure timely response to queries and documentation of study-related issues.

• Disburse investigational products, manage inventory, and provide patient education as necessary.

• Contribute to the development and implementation of tools, processes, and training for clinical studies.

• Ensure site compliance with subject safety reporting and escalate issues as needed.

• Demonstrate professionalism and apply leadership practices.

• Train and support study team members on communication and teamwork best practices.

• Perform other duties related to clinical trials as delegated by the Principal Investigator.

Essential Skills

• 5-10 years experience as a Clinical Research Coordinator on pharmaceutical trials.

• Ability to work independently.

• Experience with phlebotomy.

• Knowledge of ICH-GCP, FDA, HIPAA, and clinical trial regulations.

• Experience with EKGs, vitals, and other patient care skills.

• Experience with vaccine trials.

Additional Skills & Qualifications

• Degree in Science or RN preferred. AS Degree with an RN may be considered.

• High School Diploma/AS Degree will be considered.

Work Environment

This role requires working on-site 5 days a week.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.