Clinical Research Coordinator for NeoTract
Posted August 14, 2017
Clinical Research Coordinator - Sponsor Company (NeoTract)
Job description on LinkedIn
Negotiable (hourly rate)
Please apply through the Linkedin portal or you can send me your CV: email@example.com, Rachel Lerner.
Employer City / Location:
NeoTract, Inc. is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. NeoTract is a very high achieving organization that operates under a set of standards that promote innovation, collaboration and integrity at all times. Customer focused, NeoTract employs a sales force of urology consultants, who strive to partner with our customers to improve their practices by offering access to superior state of the art healthcare.
Technical Team Coordinator for Medicines 360
Posted August 8, 2017
The Technical Team Coordinator provides a high level of administration, coordination, and organizational support to the technical teams: Clinical/Medical, Regulatory, Quality, and Product Development. S/he is responsible for meeting arrangements, travel and expense reports, document management, and project management support. S/he will assist in the maintenance of the Medicines360 Trial Master Files (TMFs), as well as maintenance of controlled documents in Veeva, and will assist in the preparation of regulatory documentation. Additional ad hoc projects to support the technical teams will be integrated into the responsibilities as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Supports Chief Medical Officer (CMO) by assuming assigned responsibilities for routine and non-routine administrative tasks
- Assists CMO and Senior team with the management of calendars
- Records time allocation for the CMO
- Assists CMO and the technical teams with meeting arrangements, event organization, travel arrangements and subsequent expense reports
- Assists the technical teams by tracking action items and progress on multiple projects
- Develops efficiencies for the technical teams
- Assist in the preparation of regulatory documents and other controlled documents, including formatting and proofreading
- Assist in the maintenance of the Medicines360 TMFs, under supervision
- Assist in the tracking and planning of departmental budgets
- Aides in preparation and planning of meetings with regulatory authorities
- B.A. or B.S. degree or equivalent qualification and experience
- Basic understanding of GxP
- High comfort level with conference calling systems, including GoToMeeting
- Strong organizational and technical skills (e.g. word processing, spreadsheets, databases, online research)
- Ability to prioritize multiple assignments in a fast-pace office environment
- Ability to work independently as well as a team player cross-functionally
- Excellent verbal, written and communication skills
- Prior experience with regulatory, quality, clinical and/or R&D teams is preferred
- Experience with drug and/or device development is preferred
Apply online at: Medicines 360 Jobs
CRA 2/Sr. CRA for Clovis Oncology
Posted August 2, 2017
CRA 2/Sr. CRA
Primarily responsible for the day-to-day activities of managing, coordinating and executing the operational efforts for Clovis Investigator Initiated Trials (IITs), with specific emphasis on the startup and execution of biomarker and pharmacokinetic research details for each IIT. Knowledge of the drug development process and documented experience working cross functionally across a Matrix Organization is critical.
This CRA2/Sr. CRA will coordinate primarily with colleagues in Global Medical Affairs, Project Management, Molecular Diagnostics and Translational Medicine, Translational Medicine Operations, and Clinical Operations, to ensure robust clinical sample management that complies with IIT protocols, timelines, and budgets. The Sr. CRA will be responsible and accountable for managing/overseeing the entire sample set up and management process for IITs through analysis and final disposition.
The successful candidate will employ their Clinical Operations and project management skill sets in support of Clovis IIT research efforts, and will work closely with colleagues to manage biomarker/PK research with high scientific integrity. Additional responsibility may be assumed for other aspects of the IIT program as they become available.
As Clovis continues to grow, the CRA2/Sr. CRA will be a key contributor towards improving existing processes and establishing new ones, including but not limited to developing/writing work instructions and SOPs to ensure effective and efficient execution of IITs.
• Work closely with Global Medical Affairs and Translational Medicine to coordinate and manage the sample collection (tissue/blood) for on-going and planned IITs that have biomarker/PK objectives in their design.
• Manage kit preparation, sample collection procedures, shipping requirements, analytical data collection/reporting for IITs.
• Ensure robust chain-of-custody for IIT trial specimens, as needed.
• Manage contracts (material transfer agreements/clinical sample agreements) with academic institutions and/or commercial partners that provide biospecimens to Clovis as part of IIT collaborative or service provider agreements.
• Ensure/verify that collaborators (institutions, tissue banks) have appropriate documentation, process and procedures in place to ensure samples are collected according to ethical and legal standards (both prospective and retrospective sampling).
• Manage IIT vendor budget negotiations.
• Coordinate with GMA on IIT budget negotiations, as needed.
• Provide IIT vendor budget forecasts that relate to all aspects of sample management (acquisition, transport, storage, analysis).
• Track, process, pre-approved IIT vendor invoices.
• Develop knowledge/understanding of regional biospecimen/biobanking applicable regulations to help facilitate protocol approvals by global ethics committees.
• Coordinate with Clovis Diagnostic Development partners on IIT work.
• Work closely with Medical Science Liaisons to obtain IIT proposals, collect documents, and interface with investigators and relevant site staff.
• Assists in managing aspects of IIT Contracts, including management of milestones achieved and associated invoicing and payments.
• Interact with Investigators and their IIT teams regarding study logistics, progress, and issues.
• Provide management with updates/metrics on progress of IITs at routine intervals, by various tracking mechanisms.
• Collaborates effectively with cross-functional management teams and external partners.
• Proactively identify and remediate IIT issues related to samples.
• Effectively collaborates with Clinical Operations and other colleagues (e.g., Medical Affairs) for input and information exchange to ensure success of all studies/programs.
• Develop, review, update, and add SOPs as company/situations evolve when applicable.
• Develops effective working relationships with business partners to achieve business goals.
• Strong project management, organizational skills, ability to prioritize and handle competing priorities.
• Knowledge and experience with a wide variety of vendors providing services for clinical and translational research.
• Experience with contract and budget development/forecasting, negotiation, vendor management; sample management.
• Experience in working across operational, research, regulatory and legal functions
• Excellent team player.
• Excellent verbal and written communication skills with the ability to communicate effectively in the English language in person, by phone and in writing.
• Good judgment and strong problem solving skills.
• Builds successful collaborations with internal and external partners.
• Detail oriented and committed to providing quality deliverables.
• Positive, flexible, self-starter, able to multi-task, manage change, and thrives under pressure
• Knowledge of GCPs for global compliance.
• Computer proficiency (MS Word, Excel, PowerPoint).
Education and Experience:
• BS or MS degree in biology or life sciences, with a strong background in health care, other scientifically related fields, or bio/pharma industry working on clinical development projects.
• 5 + years of experience in industry.
• Experience in US/Ex-US Investigator Initiated Trials desired.
This is an office based position with some travel, approximately 10% domestic and 5% international.
Competitive in the industry and Bay Area
Employer City / Location:
San Francisco, CA
Clovis Oncology is an international, small biotech company developing oncology drugs with companion diagnostics to help patients through excellent science.