Reports To: Executive Director, Head of Clinical Operations
Position Type: Salaried, negotiable according to experience and fit; package includes company stock options, as well as tax advantaged employee benefit plans.
Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within.
Every member of our team plays a significant role in our success. Tocagen hires individuals who share our passion for ending cancer mortality and have exceptional talent that will contribute to this goal.
The Senior Clinical Research Associate’s function will include, but not limited to, oversight of the field contract monitors, as well as primary liaison with sites for the assigned protocols. Duties may include performing qualification initiation, interim monitoring and close out visits of one or more sites for designated projects in accordance with GCPs and applicable SOPs (e.g. source data verification, patient recruitment, drug accountability, data collection, and collecting regulatory documentation). As a member of the SMT, this position is responsible for providing site updates as well as identifying potential risks to the project. Lastly, this position must establish a close working collaboration with Study Managers and the rest of study management team.
Duties and Responsibilities Include But Are Not Limited To:
- Assists in development of study materials, case report forms (CRFs), and informed consent documents for clinical studies as needed.
- May participates in investigator site selection.
- Supports TMF completion.
- Verifies study data and facilitates the resolution of data queries and requests from Data Management.
- Assists in coordinating activities for the conduct of clinical studies and interactions with CROs and other outside vendors.
- Maintains all relevant site communications and both trial and site master files.
- Communicates regularly with sites and is aware of the activities of assigned clinical sites.
- Conducts and coordinates all activities which include report writing associated with initiation, interim monitoring, study close outs, and audit visits as assigned.
- Communicates with internal departments as needed, including attending required meetings and following-up on action items.
- Assists in development of departmental processes, SOPs and personnel training programs.
- Supports all audits, as needed.
- Travels to study sites as needed.
- Performs other duties as required.
Desired Knowledge and Abilities:
- Strong working knowledge of medical/scientific terminology and knowledge of FDA regulations, GCP, and ICH guidelines is required; knowledge of NIH guidelines are a plus.
- Well versed in various eDC systems.
- Excellent planning, problem solving skills and customer service mindset is required.
- Computer skills required; must be proficient in Microsoft Word, Excel and PowerPoint.
- Ability to multitask effectively to meet deadlines in a dynamic environment is essential.
- Requires strong organizational and presentation skills, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment.
- Excellent communication skills and ability to communicate effectively with all levels at the clinical sites.
- Knowledge of operating room procedures, etiquette, and sterile procedures is a plus.
- Flexibility; ability to travel up to 50-60%+ if required.
Education & Experience:
- BA/BS or RN degree required.
- Minimum 5 years of CRA experience; Oncology experience strongly preferred.
- Nursing or surgical tech experience desired.