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Reports To: Director, 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 Clinical Research Associate (CRA) will perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH E6 Good Clinical Practices, FDA guidelines, local regulations and standard operating procedures or work instructions.
The CRA works as part of the Study Management Team to contribute towards the management and execution of Clinical Programs. The CRA is also responsible for oversight of the field monitors.
Duties and Responsibilities Include But Are Not Limited To:
- Conduct pre-study, initiation, routine monitoring and closeout visits of study sites (as required).
- Co-monitoring and oversight of CRO or contract CRAs for pre-study, initiation, routine monitoring and closeout visits.
- Perform all aspects of study site management both whilst on-site and remote site management.
- Verify compliance and quality of collected data.
- Verify the receipt, handling, accounting, storage conditions, and availability of clinical products and supplies.
- Verify study data and facilitate the resolution of data queries and requests from Data Management.
- Conduct and coordinate all activities including report writing associated with initiation, interim monitoring, study close out and audit visits as assigned.
- Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations.
- Support TMF set-up, ongoing quality review, and final reconciliation of study documents.
- Participate in study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation.
- Contribute to and/or develop the Monitoring Plan and ensure appropriate quality and timely monitoring of clinical sites.
- Assist in development of study materials, case report forms (CRFs), informed consent documents for clinical studies, as needed.
- Prepare or provide input into status reports and act as primary contact for field CRAs regarding project activity.
- Ensure management of Trial Master File.
- Keep the Clinical Operations lead informed of the progress of projects for which designated responsibility.
- Development and maintaining of good working relationship with investigators and study staff.
- Assist in the organization and participate in investigators’ meetings (as applicable).
- Perform protocol specifics as well as GCP training for site personnel.
- Assist in development of departmental processes, SOPs and personnel training programs.
- Serve as point of contact for site personnel.
- Perform other duties as required.
Desired Knowledge and Abilities:
- Proven clinical monitoring skills.
- Demonstrated understanding of medical terminology.
- Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures.
- Customer focus.
- Good organizational and time management skills.
- Effective interpersonal skills.
- Attention to detail.
- Proven flexibility and adaptability.
- Ability to work in a team or independently as required.
- Good English language and grammar skills.
- Good presentation skills.
- Computer skills required-must be proficient in Word, Excel, and PowerPoint.
- Excellent communication skills, ability to communicate effectively with all levels at the clinical sites and good people skills critical.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.
- Flexibility; ability to travel up to 50-60%+.
Education & Experience:
- BA/BS or RN degree required.
- Minimum 2 years of CRA experience; oncology preferred.