Clinical Trial Associate – Clinical Operations (m/f)
|Main focus:||Clinical Operations|
HOOKIPA is seeking a Clinical Trial Associate (CTA) to support our trial managers in the planning and implementation of clinical trials. The CTA will work collaboratively within study teams and across functional areas, under the guidance of a clinical trial manager. This position can be considered as an entry level position. Direct prior experience in the field of clinical research is welcome but is not required. The CTA position is a great learning experience designed to introduce a new team member to managing clinical trials at a biopharmaceutical company and is a stepping stone for further development in the clinical trial operations field. The successful candidate will be an organized self-starter with a collaborative attitude, willingness to learn from mentors, and have the ability to complete project tasks with attention to details.
- Assist the Clinical Trial Manager (CTM) with achieving key study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, study execution, data collection, and close-out.
- Attend study team or sub-team meetings and record minutes as required
- Review consistency within and across study documents (e.g. protocol and other study documents such as lab manual, pharmacy manual, etc.)
- Assist with CTM with vendor management tasks such as attending meetings, communicating deadlines, and reviewing materials in accordance with a team-defined plan.
- Support biosample tracking from sites to central lab sample management to central analytical lab.
- Perform administrative tasks to support team members with clinical trial execution as needed.
- Collaborate with the development of data collection tools. Participate in user acceptance testing, review documentation, and provide input to study plans.
- Support the CTM for review and processing of invoices, including tracking, if required,
- Create and review various study-related trackers to determine and report status of clinical trial documents (i.e., protocol, investigator’s brochure, informed consents, etc.)
- Generate mass mailings upon request of the CTM.
- Oversee and audit maintained documents in the trial master file.
- Participate on teams and special projects as required. Must be flexible to assist at any time to meet the needs of the team.
- This can be considered an entry level position that is designed to introduce a new team member to the field of clinical operations and managing clinical trials. Direct prior experience in the field of clinical research is welcome but is not required.
- Minimum education: Completion of BA/BS, preferably in a related scientific or healthcare field
- Prior experience preferred but not required including experience in clinical research (e.g. clinical research coordinator in academic or healthcare setting; clinical trial associate at a contract research organization or pharmaceutical company, etc.)
- Microsoft Office 365, including Excel (experience with inputting, tracking data, formulas)
- Strong communication skills (verbal, written including email). Must be able to draft summary of discussions.
- Vendor management (working with external vendors, organizing external team members)
- Self-starter, proactive
- Willingness to learn
- Attention to detail and commitment to quality
- Strong organizational skills. Have the ability to organize various information into a table or chart for management.
- Ability to work independently in a self-directed manner
- Team player with the ability to build relationships
- Ability to identify tasks, prioritize tasks, multitask
- Flexible and adaptable
What we offer
- Strong team with dedicated and passionate employees
- State of the art infrastructure
- An excellent working atmosphere
- Opportunities for personal development
- Working in a multinational and multicultural environment
Currently remote until safe office-work / commuting can resume. Intention for position to be office-based in midtown Manhattan upon the resolution of the COVID-19 pandemic.
We offer a comprehensive package with competitive salary, paid holidays and sick leave, along with a full range of medical, dental/vision insurance and 401(K) plan. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.