What are the responsibilities and job description for the Clinical Trials Associate position at Janux Therapeutics?
Clinical Trials Associate
Reporting to our Director of Clinical Operations or Clinical Trial Manager, the Clinical Trial Associate will participate in planning and assisting in managing the conduct of clinical trials in accordance with company policies and procedures and applicable regulations.
This position is a key member of the clinical trial team, responsible for providing administrative and operational support throughout the duration of a clinical study.
\n- Supports the clinical operations project teams under the supervision of Clinical Trial Managers.
- May contact clinical trial sites, vendors, CROs, and partners as needed.
- Performs administrative tasks to support clinical project teams.
- Maintains the Trial Master File (TMF).
- Prepares meeting agendas, meeting minutes, and tracking logs.
- Tracks clinical trial progress, including enrollment tracking, status update reports, and other reports as needed for assigned clinical trials.
- Submits applicable documents to the Trial Master File (TMF).
- Follows applicable Standard Operation Procedures (SOPs)
- Assists with the creation and maintenance of documentation for assigned clinical trials. Documents may include, but not limited to: presentations, pharmacy manuals, regulatory binders, lab manuals, and training materials.
- Partners with external vendors for accurate distribution of all clinical trial-related materials to clinical trial sites or clinical team members.
- Responsible for scheduling internal meetings and meetings with external collaborators
- Responsible for meeting minutes.
- Assists with creation and distribution of study-level communication to stakeholders
- Supports the study team by proactively identifying, resolving, and/or escalating issues to assigned staff.
- Under general supervision collects, processes and tracks investigator sites and regulatory documents required by the FDA, and other regulatory authorities, as necessary across multiple studies.
- Coordinates, processes, and tracks shipments (i.e., supplies, study-related materials, etc.)
- Serves as a point of contact for clinical supplies, document collection and preparation for close-out.
- Prepares and maintains documents and files such as clinical study files, regulatory binders, and operations manuals for clinical sites (i.e., informed consent form, protocol and investigators brochure).
- Assists with the quality review of documentation e.g., ICFs, regulatory green light packages.
- Attends study and Departmental meetings
- Capable of handling additional tasks with little supervision.
- BA/BS in equivalent field with 2 years of experience in Clinical Operations or equivalent experience without degree.
- Oncology experience preferred
- Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Excellent written and verbal communication skills.
- Ability to multitask.
- Significant attention to detail, time management and organizational skills.
Job Type: Full-time
Benefits:
401K
Medical insurance
Dental insurance
Vision insurance
Supplemental disability insurance plans
Flexible schedule
Life insurance
Flexible vacation
Sick time
Incentive stock option plan
Relocation assistance
Schedule:
Monday to Friday
Work authorization:
United States (Required)
Additional Compensation:
Annual targeted bonus 10%
Work Location:
On site (San Diego, CA)
EQUAL OPPORTUNITY EMPLOYER:
Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
Salary : $90,000 - $110,000
