Senior Clinical Research Associate

About RDI

Research & Development Institute (RDI) is a leader in the Clinical Research industry, with over 110 clinical trials completed since its establishment in 2008. The company boasts a national network of physicians & labs and supplies the largest In Vitro Diagnostic companies with the research data they need to improve healthcare worldwide.

RDI is seeking a Senior Clinical Project Manager to lead a team of 6-7 Associates and manage our network of physicians and labs to execute clinical trials on-time and on-budget. This is a long term career position with significant room for growth as our company expands nationwide.

Responsibilities

• Manage multi-site, multiple clinical trials on daily basis focusing on scope, budget, schedule, risks, issues and resources
• Develop overall clinical trial and site budget based on project trial complexity, number of study participants, study visits and procedures
• Plan project through developing a work breakdown structure (WBS), defining and refining tasks, milestones, deliverables, resource assignments, estimates, and developing contingency plans Responsible for all project timelines and deliverables.
• Evaluate and communicate the impact of risks, develops project quality and risk management plans for performance. Accountable for monitoring management, project deliverables in accordance with project plan.
• Manage cross-functional project team including protocol development team, regulatory team, physicians/investigators, study coordinators, study nurses, study recruiters, Clinical Research managers and Research Associates. Worked with and directed multiple sponsors/vendors, including other Contract Research Organization (CRO), Institutional Review Board (IRB).
• Assist in identification, evaluation, and selection of investigative sites Provided leadership in developing new clinical trials study-related documents, including protocols and SOPs; manage ICF development and programming of eCRF pages
• Communicate the status of the projects on a regular basis to the sponsors, principal investigator and stakeholder teams using graphic illustrations and concise reports Ensure the scientific integrity of clinical studies and oversee clinical and research laboratory data QA/QC processes at the clinical trial sites
• Engaged in hiring internal project team and interviewing teams for other functional areas, along with employee appraisals and disciplinary actions, if needed.

• At least 7 years of experience managing Clinical Trial Projects
• Demonstrated leadership skills
• Knowledge of the In Vitro Diagnostic industry preferred, however Pharma candidates will be considered

• A direct, confident, self-starter that is excited to be given the freedom to achieve their potential