Coordinates the activities associated with the evaluation, initiation and management of clinical trials. Manages clinical studies, including CRO oversight. Coordinates the training of staff involved in trial management.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manages clinical trials, including those conducted through Contract Research Organizations
May hold the role of Study Team (ST) Facilitator, and is responsible for the setting of agendas, effective facilitation of ST meetings, and the timely issuance and distribution of meeting minutes
Serves as primary contact for Exelixis functional area representatives and vendors and is responsible for protocol execution
Maintains regular internal contact with relevant departments such as Regulatory Affairs, Drug Safety, and others as necessary
Responsible for the day-to-day interaction with CROs in the execution of ongoing clinical trials
May assist with the development and review of study protocols, informed consent forms, case report forms, monitoring plans, study materials and monitoring tools
Establishes study milestones and ensures accurate tracking and reporting of study metrics
Performs CRO oversight activities such as Trip Report Review, TMF review and co-monitoring visits, per Study Plans. Provides written documentation of all activities including issues and findings in Spreadsheets or databases
Co-monitors clinical study sites; writes and reviews reports for PSSVs, SIVs, IMVs, and COVs as required
Assists in the management of external vendors (e.g., clinical labs, study assessment labs)
Performs operational feasibility assessments for new clinical protocols
Supports efforts geared to prepare clinical sites for regulatory inspections
Helps identify and recruits clinical investigators
Reviews sample, investigator-prepared and IRB-approved informed consents
Coordinates the design, format and content of study guides and subject instructions
Coordinates the activities associated with site start-up and management
Coordinates the arrangements for investigational product
May coordinate the preparation, conduct and presentations at Investigator Meetings
Manages the overall Investigational product accountability and reconciliation process
Ensures that that CRF data queries are resolved
Coordinates CRO tracking, and training, including central laboratories
Provides study-specific outsourcing specifications for RFPs
Coordinates CRO relationships and performance
Ensures compliance with Exelixis policies and procedures.
May assist in the preparation of Clinical Study Reports, Annual IND safety reports and clinical summaries, as required.
May monitor clinical sites for adherence to protocol and GCP
May supervise staff and assign work
SUPERVISORY RESPONSIBILITIES:
None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
BA/BA/BSN in biological sciences or related field and a minimum of seven years of related experience; or
MS/MA/MSN in biological sciences or related field and a minimum of five years of related experience; or
PhD/PharmD in biological sciences or related field and zero or more years of related experience; or
Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
Typically requires a minimum of 7 years of related experience in life sciences, including 5 years in experience in clinical research
Knowledge/Skills:
Experience in either starting a study up, closing out a study, or working on the maintenance phase of study
Experience with development of prospective site-selection criteria
Protocol development experience
Familiar with advanced concepts of clinical research
Ability to deal with time demands, incomplete information or unexpected events
Experience in interactions with outside vendors, e.g., CROs and contract labs
Experience with administration of site budgets and grants with supervision
Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations
Demonstrated ability to write and present clearly using on scientific and clinical issues terminology
Advanced computer skills
Good organizational and planning skills
Strong interpersonal skills and communication skills (both written and oral)
Ability to work effectively in a team/matrix environment
Ability to understand technical, scientific, and medical information
Familiar with basic concepts of clinical research
Ability to problem-solve
WORKING CONDITIONS:
Environment: primarily working indoors, performing clerical work
Up to 25% of travel
#LI-KN1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.