Description:

Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and SOPs

• Coordinate, with supervision, assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.

• Implement research and administrative strategies to successfully manage assigned protocols.

• Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.

• Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries

• Maintain confidentiality of patient protected health information, sponsor confidential information and confidential information

• Ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and SOPs.

• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner

• Ensure staff are delegated and trained appropriately and documented

• Create, collect and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.

• Evaluate potential subjects for participation in clinical trials including phone and in person pre-screens.

• Execute recruitment strategies defined by Clinical Research Team

• Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.

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.