Director of Research Activities

Director of Research Activities



Lotus Clinical Research, Inc conducts high-quality inpatient clinical research studies for global pharmaceutical & biotech sponsors, specializing in the evaluation of drugs and devices used in the peri-operative arena. We are seeking a Director of Research Activities with at least 5 years clinical research experience to manage our Phase I inpatient research site at Huntington Memorial Hospital in Pasadena.



Job Responsibilities include:

Manage Phase I site, leading logistical site expansion plans. Work with executive team on business development initiatives and other strategies; develop policies and procedures to meet company goals.

Manage multiple clinical research trial project timelines through all lifecycle phases. Provide leadership in the development of trials and related documents. Coordinate and manage clinical studies (predominantly Phase I) including but not limited to:

Identify resources needed (including staff) to meet target outcomes for study



Track and manage resources, timelines, and budgets



Ensure clinical trial management system (Study Manager) reflects trial status



Provide clear, accurate and timely information flow and status updates internally and externally



Ensure studies are audit-ready at all times



Address any result findings in timely manner



Lead the team to deliver projects on time and within budget, according to required standards of quality and compliance. Ensure adequate participation, contribution and accountability of the study team members. Establish team performance expectations.

Ensure quality and adherence to relevant SOPs, GCPs, regulatory guidelines, and other working practices. Ensure appropriate response to new safety information (e.g. update of trial documents). Identify project risks, develop and implement mitigation strategies.

Qualifications:

Bachelor’s degree required; master's degree preferred



Minimum 5 years directly relevant clinical research experience; phase 1 site management experience strongly preferred



Ability to provide leadership and tactical guidance to clinical team



Experience successfully working with monitors and sponsors



Deep knowledge of data management and statistics



Business development and negotiation skills



Demonstrated knowledge of laws, regulations, standards and guidance governing the conduct of clinical studies



We offer a very competitive compensation package, including substantial compliance bonuses, benefits package with medical, dental, vision coverage, and matching IRA contributions. Lotus CR is an Equal Opportunity Employer.

If you are interested in applying, please e-mail your resume as an attachment in MS Word format to: hr@LotusCR.com