Sr. CRC

The Clinical Research Coordinator will serve as leader of a study team to execute clinical trials

• Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills

• Create training strategies and mitigation plans

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

• Implement and coordinate 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.

• Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study

• Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.

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

Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries

• Ensure confidentiality of patient protected health information, sponsor confidential information and confidential information is maintained by all team members

• Develop communication and escalation strategies within teams to that 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

• Ensure the creation, collection and submission of 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.

• Create and execute recruitment strategies in conjunction with patient recruitment staff

• Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol.

• Incorporate understanding of how decisions affect the bottom line including links between operations and company’s financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol.

• Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol

• Develop Quality Control strategies for team member projects

Additional Skills & Qualifications:

At least 6 months of experience in clinical research is required

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

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