EMPLOYMENT OPPORTUNITIES
JANIX, an EEO, does not have any current employment openings at this time. However, if you would like to submit your CV for future consideration, you may do so for the following positions:
Full-time Regional CRA/Site Manager
Full-time Clinical Study/Project Manager
Full-Time In-House Clinical Research Associate
Full-Time Clinical Study Assistant
For consideration of open positions, please forward CV and salary requirements to: HR@janix.com
FULL-TIME REGIONAL CRA/SITE MANAGER
This will be a fully independent home based position (multiple positions on the west coast, east coast, mid-west and/or south). This position will be responsible/ accountable for the identification, selection, set-up, monitoring and close down of investigational trial sites in one or more programs.
This person will be completely accountable for the site management and data quality of each site for which they are responsible. They must be able to operate a home based office and be fully functional as a home based monitor/site manager. This would include generating correspondence and reports without administrative help, making one's own travel arrangements, general clerical duties associated with managing a home based office and the ability to anticipate, trouble shoot and resolve various types of problems and issues independently and without peer support. This person will also be expected to develop a rapport with potential investigators, representing many different medical specialties to facilitate the placement of future research studies at institutions and medical centers.
Salary: Depends on experience. This full time position comes with medical dental, and life insurance, and 401K, Profit Sharing and FSA benefits.
Requirements: Bachelor Degree or above. MINIMUM of 1 year regional monitoring experience in Phase I through IV studies and at least 2 years in the pharmaceutical industry. This candidate will be based in their home office and will be required to travel regionally up to 40- 50% to monitor Phase I through IV studies. Strong computer literacy (MS Word, MS Excel, MS PowerPoint and MS Outlook (Email and Calendar).
FULL-TIME CLINICAL STUDY/PROJECT MANAGER
(Home Based and Office Based Positions Availabe)
This position will support the Development department with regard to the management of clinical studies. Also the role of a Clinical Study/Project Manger includes the support of the processes of supplier selection and management.
The Clinical Study Manager is responsible and accountable for a particular study from the point in time where the Study Protocol Synopsis is available until the Data base lock and until the Trial Master File (TMF) is archived.
The role is established in order to oversee and manage all activities related to the clinical study, including:
- Overall management of study
- Plan and prepare study
- Conduct study
- Close out study
The Clinical Study Manager leads the study team for a particular study.
Roles & Responsibilities
| The Clinical Study Manager's general responsibilities include to: - Lead and guide the Study Team - Keep close contact to study-related functions - Support external supplier selection and management of supplier during the study - Track and control the study and keep the study within the given timelines and budget - Ensure quality of all steps in preparation, conduct and closure phase of the study by following both national and international laws and guidelines (e.g. ICH/GCP) and GRT SOPs |
More specifically, the Clinical Study Manager will: - Compile and review documents necessary for FDA submission - Compile and review documents necessary for IRB submission - Compile and review answers to questions raised by FDA or IRBs - Select local monitors and sites to be co-monitored - Develop a co-monitoring plan - Review and comment co-monitoring report - Coordinate and/or communicate information to other study related functions - Define criteria for evaluation of supplier proposal - Confirm and coordinate outsourcing with the study team and the CRO Manager - Budget tracking functions - Maintain methodologies, tools and templates on a regular basis; e.g. Study Plan and Study Status Template - Other responsibilities as assigned. |
Job Requirements
| Education: - Bachelor degree or above preferable in a Life Science or Nursing/Medical - Managerial expertise, especially in managing studies - Good clinical operational knowledge (minimum 3 years of pharmaceutical industry clinical operations experience and hands on monitoring experience) Industry-specific knowledge: - Experience working for an international pharmaceutical company highly desirable - Proven project management skills (including planning and tracking) - Strong implementation skills - Solid understanding of budgeting and financial tracking - Knowledge of clinical data management, statistical processes, report writing, regulatory and drug safety requirements |
Personal skills & abilities: - Team building and leadership skills - Ability to coach and teach team members - Strong communication skills - Ability to interact and network effectively - International/ intercultural working experience - Delivery focused - Problem identification and issue resolution skills - Ability to motivate Study Team to deliver - Ability to provide objective feedback - Attention to detail and follow-up |
FULL-TIME IN-HOUSE CLINICAL RESEARCH ASSOCIATE
Office Based in CA.
PURPOSE: To provide in-house management support for Clinical Projects
RESPONSIBILITIES and Primary Tasks:
- To be fully aware of study requirements
- Familiarization with study protocol
- Attendance at clinical project team set up meetings
- Attendance at Investigator meetings, where appropriate
- Understanding administrative scope of work
- Selection of study sites
- Search Investigator databases to identify potential investigators
- Submission of regulatory applications
- Eestablish list of required regulatory documents and establish/manage formal tracking system
- Manage clinical trial supplies and maintain documentation throughout Organization of Investigator meetings
- Prepare Investigator Site Files, Financial Agreements and other essential documents required for initiation of the site
- Oversee the Regional CRAs tasks of monitoring of the Study including tracking of lab supplies, sample shipments, CRF delivery, data collection tracking, and investigator payments
- Receive phone calls from sites, answer queries, redirect calls or otherwise respond appropriately
- Update tracking system appropriately
- Participate in regular team meetings/teleconference to centrally co-ordinate and archive the clinical study documents
- Set up the in- house Central Study Files, Manage the receipt, copying and filing of clinical documents
- Co-ordinate retrieval of clinical documents to assist with audits
- Make arrangements for archiving the clinical documentation at the end of the study
QUALIFICATIONS:
Bachelors Degree, or above
EXPERIENCE:
1 year or above in a CRO or biopharmaceuticals position.
FULL-TIME CLINICAL STUDY ASSISTANT
Office Based in CA.
PURPOSE: To provide in-house administrative support for Clinical Projects
RESPONSIBILITIES and Primary Tasks:
- To be fully aware of study requirements
- Familiarization with study protocol
- Attendance at clinical project team set up meetings
- Aattendance at Investigator meetings where appropriate
- Understanding administrative scope of work to assist with selection of study sites
- Search Investigator databases to identify potential investigators
- Assist with submission of regulatory applications
- Eestablish list of required regulatory documents and establish/manage formal tracking system
- Manage clinical trial supplies and maintain documentation throughout
- Assist with the organization of Investigator meetings
- Assist with the initiation of Study Sites
- Prepare Investigator Site Files, Financial Agreements and other essential documents required for initiation of the site
- Assist with the administrative monitoring of the Study including tracking of lab supplies, sample shipments, CRF delivery, data collection tracking, and investigator payments.
- Receive phone calls from sites, answer queries, redirect calls or otherwise respond appropriately
- Update tracking system appropriately
- Participate in regular team meetings/teleconference to centrally co-ordinate and archive the clinical study documents
- Set up the in- house Central Study Files, Manage the receipt, copying and filing of clinical documents
- Co-ordinate retrieval of clinical documents to assist with audits
- Make arrangements for archiving the clinical documentation at the end of the study
QUALIFICATIONS:
Associate Degree, or equivalent, in an appropriate discipline, e.g. commercial administration, health care, languages
EXPERIENCE:
Administrative experience in providing support to a team in a flexible and proactive manner. Setting up files, scheduling meetings, meeting minutes,. Experience in clinical trials, CRO or biopharmaceuticals a plus.