The Clinical Research Manager will join the dynamic and fast-paced clinical research team at Curative Inc. to lead clinical trials from ideation to study closeout. The Clinical Research Manager will manage and monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP guidelines, and all applicable regulatory requirements. The Clinical Research Manager will supervise CRCs, study coordinators, and field staff, and help to develop and implement clinical research processes, procedures, and programs. 

ESSENTIAL DUTIES AND RESPONSIBILITIES 

• Manage the full scope of clinical studies including, but not limited to, protocol development and implementation, site selection, site monitoring, staff training and supervision, enrollment, maintenance, study/site closeout, and data analysis and reporting.
• Prepare and review study related plans and documents including protocols, informed consent forms, recruitment plans, protocol deviation plans, case report forms, and other applicable study-related documentation.
• Develop study timelines, budgets, and outline project milestones.
• Ensure Trial Master File (TMF) is current and maintained. 
• Manage cross-functional projects that involve multiple stakeholders, vendors, patients, and providers. 
• Work cross functionally with various departments within Curative on all aspects of the clinical trial and serve as the liaison between internal teams and external partners. 
• Improve existing operational processes and implement new procedures.
• Author/contribute to clinical study reports and manuscripts. 
• Develop and implement SOPs.
• Work adhering to US regulatory and Quality System requirements (21 CFR 820, etc).
• This position assumes and performs other duties as assigned.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:

• Proven track record of leading initiatives, hitting goals, and succeeding in a fast-paced team environment.
• A ‘hold on and don’t let go’ attitude for problem-solving.
• Expert communication and interpersonal skills.
• Advanced Excel skills, Microsoft office, and GSuite skills.
• Must possess superior analytical and creative thinking skills.
• Excellent attention to detail and the ability to keep detailed, accurate records.
• Understanding of laboratory procedures and equipment.
• Advanced organizational and planning skills.
• Ability to stand for extended periods of time.
• Must be fluent in English and possess solid writing abilities.
• Willingness to travel throughout the greater LA area and be present at field operations where people that are currently or formerly infected with COVID-19 may be present (such as a testing site).

EDUCATION and/or EXPERIENCE

• Bachelor's degree (B. S./B. A.) in life sciences or related field from four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience.
• 3 years of experience in Clinical Research. Experience with in-vitro diagnostics is a plus. 
• Detailed knowledge of GCP/ICH guidelines and other US clinical regulatory requirements.
• Working experience with an electronic data capture system (EDC), CTMS, and eTMF system.
• High-growth or early-stage start-up experience or a demonstrable ability to operate through ambiguity.

CERTIFICATES, LICENSES, REGISTRATIONS

Must complete CITI training within 30 days of employment.