Senior Clinical Trials Assistant
This is not a remote position and the requirement is to be onsite in San Diego, CA.
The Senior Clinical Trials Assistant (CTA) is accountable for all clinical document management and TMF oversight and reconciliation responsibilities, accountable for clinical trial disclosure management according to regulations, tracking and supporting GCP Inspection readiness activities for AnaptysBio-sponsored studies through Clinical Development. The Sr. CTA will also support cross-functional study management teams ensuring effective and efficient conduct of clinical research studies by providing administrative and project tracking support as assigned.
- Provides support to clinical study manager(s) and director(s) of clinical operations on study management activities.
- Communicates trends and helps to prepare updates to senior management on status of study conduct. Informs the study manager/project team of progress of projects and tasks for which he/she has designated responsibility.
- Participates in essential documents and regulatory package as part of study oversight team.
- Coordinates project team/Investigator meetings and generate meeting minutes as required.
- Assists with the production of project/protocol slides, presentations and study-related reports, etc., as needed for project, departmental, sponsor and/or business development presentations.
- Assists with the production and/or review of study-related Clinical Operations guidance documents (e.g. Trial Master File Maintenance Plans, Monitoring Plans, etc).
- Coordinates of team member and or external meeting attendance tracking.
- Sets up, organizes and maintains clinical study documentation (e.g. Main Study Files, CRFs, etc.) such that it is audit ready and available for final reconciliation and archival.
- Monitors and contributes to CDA/CTA development and reviews and uploads documents into appropriate systems. Manages communications between stakeholders to ensure timely processing of documents.
- Coordinates ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.
- Contributes to regular internal quality control audits of clinical study documentation. Serves as Clinical Development liaison in audits directed by regulatory authorities (e.g. FDA, MHRA, etc) and as primary point of contact for Clinical documents and study related files.
- Participates as study team member with development and/or review of study- specific documentation, materials and guidelines as appropriate.
- Tracks distribution of safety reports. Arranges for document translation, if required.
- Updates relevant Clinical Trial Management systems with trial progress.
- Tracks Investigator and vendor payments and accruals, if applicable.
- Works with CSM/Sr. CSM on updates needed to clinicaltrials.gov and other clinical trial registrations.
- Contributes to SOP development, reviews and departmental process improvement efforts.
Knowledge and Competencies
- Understanding of ICH GCP, regulations, relevant SOPs and internal tracking systems.
- Good organizational skills, ability to multi-task and meticulous attention to detail.
- Ability to work in a cross-functional team or independently, as required.
- Able to develop and maintain good working relationships with investigators, staff and vendors.
- Effective interpersonal skills.
- Flexible and adaptable team member who takes initiative in a frequently changing clinical environment.
- Good written and verbal communication skills.
- Ability to maintain confidentiality of proprietary information.
- Proficient in Microsoft Word, Excel, PowerPoint, Outlook.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus for reading documents.
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
May be required to travel by plane or car <10% of the time for domestic and/or international travel.
Education & Experience
- BA or BS in scientific/healthcare or life sciences field, or BSN.
- 4-6 years of clinical support experience.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.