(US-California) DRUG SAFETY ASSOCIATE, for our client, a Bay Area biopharmaceutical company. JOB DESCRIPTION The Drug Safety Associate will manage adverse event reports from both clinical and post-marketing setting. Working in conjunction with the Director of Drug Safety, Medical Directors, other members of Clinical and Medical Affairs, and Regulatory Affairs, s/he will ensure acquisition of appropriate information, assessment of the adverse events, and timely reporting of SAEs including expedited and annual reporting. S/he will also perform the triage for adverse events to determine regulatory reporting requirements and contact investigators, coordinators or other consumers to solicit comprehensive information about reported adverse events as well as relevant follow-up information. S/he enters cases into the safety database, writes case summaries, and performs analysis of similar events. Additional duties include reviewing literature of clinical and preclinical reports to provide the context for all reported serious adverse events, preparing IND safety reports for medical review by the Director of Drug Safety and for filing by Regulatory Affairs with the FDA and other appropriate agencies, and participating in reconciliation between clinical trial and safety databases. The Drug Safety Associate will communicate with corporate partners regarding safety issues, coordinate and oversees the notification of investigators and IRBs of IND safety reports, assist the Drug Safety Director in responses to inquiries for safety information and preparation of periodic safety reports, and assure SOPs are appropriate and the personnel are trained accordingly. S/he will also participate in safety related education programs for internal and site personnel, and participate in writing the safety sections of clinical protocols and CRFs. QUALIFICATIONS The ideal candidate will have a PharmD, RN, MSN or equivalent complemented by a minimum of three years of experience in the pharmaceutical industry. A knowledge of GCP adverse event reporting guidelines, excellent written and verbal communication skills, and organization skills are also required. S/he must be self-motivated, able to function independently and as a team member and have attention to detail. COMPENSATION Compensation is competitive and includes a base salary between $70K-$80K as well as a comprehensive benefit package. Relocation is available.
(US-California) CLINICAL DATA SPECIALIST, for our client, a Bay Area biopharmaceutical company. JOB DESCRIPTION The Clinical Data Specialist will oversee and coordinate clinical data management activities in support of clinical research studies, including editing and coding of data, QC and QA audits, and interaction with CROs and contractors. S/he will perform or direct database design, development and validation, lead selected teams in CRF design, and ensure that the clinical data management activities adhere to timelines and SOPs. Additionally, s/he will lead the team selected to design case report forms, maintain a thesaurus management system, prepare the clinical data plan for each trial, assist in development, training and maintenance of department SOPs. S/he will create custom queries, procedures and reports, resolve data discrepancies in clinical studies, and evaluate new procedures or technologies to increase productivity without sacrificing quality. QUALIFICATIONS The ideal candidate will have a Bachelors degree complemented by three to five years of relevant experience in the pharmaceutical industry. S/he will have an understanding of clinical practices, regulatory requirements, and overall data management process. Knowledge of SAS, data processing experience with clinical databases, and the ability to use SQL, PLSQL, Oracle Reports for customizing queries, procedures and outputs is also required. COMPENSATION Compensation is competitive and includes a base salary between $50K-$65K as well as a comprehensive benefit package. Relocation is available.
(US-California) CLINICAL RESEARCH MANAGER in southern California, for our client, a prominent medical device firm. DESCRIPTION In this in house position, the Clinical Research Manager is responsible for clinical trials oversight and leadership through effective management and integration of the project team. S/he will be directly responsible for managing, planning and execution of Phase I-IV multi-site clinical device trials in the US and possibly abroad. This position will have operational and project responsibilities. Specifically, this individual will facilitate the site selection and recruitment process, conduct investigator meetings and selection, and develop and deliver study specific material (e.g., tracking logs, templates, monitoring tools, study binders, process manuals). S/he will set-up project files and determine maintenance requirements and a quality control plan; communicate to the team and ensure appropriate training takes place, and work with the key functional departments to coordinate the project-related activities to meet project goals and milestones, based on the study design. S/he will also manage project resources, timeline, budget, and staffing and set appropriate project expectations (e.g., milestones, time lines, project scope) with sponsors, team members and their direct reports. S/he will manage staff and step in where needed. QUALIFICATIONS Candidates will have at a minimum a master’s degree in a science-related field, with an M.D., O.D. or Ph.D degree strongly preferred. S/he will have a minimum of seven years of clinical experience in the Pharmaceutical/CRO or medical device industry as well as demonstrated experience, at least three years minimum, in clinical project or trials management tasks (e.g., work plans, financial budgets, timelines, status reports, issue management, resource and personnel management). A focus in Ophthalmology is preferred but not mandatory, but experience working on a team across multiple functional areas and strong knowledge of clinical trial operations and international experience is all preferred. The ideal candidate will have a demonstrated ability to successfully supervise and lead others as well as excellent communication, relationship building and interpersonal skills and organizational skills and ability to prioritize and multi-task Travel will be around 25%, with the opportunity for international travel as well. COMPENSATION Compensation is competitive and includes base salary range of $85K-$105K and a comprehensive benefit package. Relocation is available.
(US-California) CLINICAL RESEARCH ASSOCIATE for our client, a large medical device firm. This is an in office position requiring between 25-30% travel. The ideal candidate will conduct on-site monitoring visits to verify that the rights and well-being of human subjects are protected; that reported trial data are accurate, complete and verifiable from source documents; and that the trial is conducted in compliance with the currently approved protocol, with GCPs, ICH Guidelines and FDA regulations. This individual is the main liaison between the site and our client and will perform pre-study visits to evaluate adequacy of site, investigator and research staff in accordance with Sponsor protocol, our client’s SOPs, GCPs, ICH Guidelines and FDA regulations. S/he will ensure that study documentation is completely and properly maintained. The ideal candidate will also prepare and submit timely appropriate monitoring forms and site visit reports in accordance with the Project Operations Manual and our client’s SOPs. S/he will also monitor Investigator compliance for the reporting of Adverse Events and Serious Adverse Events to our client and/or the Sponsor and the IRB. This is a great role for someone looking to reduce their overall travel. QUALIFICATIONS The ideal candidate will hold a Bachelor’s Degree in a scientific discipline or equivalent applicable experience such as a Nursing Diploma. RN, CCRA or CCRC certification preferred. Specific experience with medical devices is very desirable, as is Ophthalmology experience. A minimum of 24 months of field monitoring experience is required, with CRO experience being preferred. In depth working knowledge of GCPs, ICH Guidelines, FDA Regulations, the drug development process and company SOPs. Excellent interpersonal skills and communication are required to be successful in this role. Candidates need to be able to accept national travel that under some circumstances will be with little prior notice. COMPENSATION Compensation is competitive with a base salary range between $60K to $70K depending on experience. The package includes comprehensive benefits as well as a friendly, casual, and energetic environment in which to work.
(New Zealand-South Island-Christchurch) To assist in development of these growing fields we are seeking an energetic and innovative PhD student to join our team. The student will conduct original research on genes involved in bacterial cell stability with the aim of understanding how bacterial cells respond to stress in their environment. You will have an appropriate excellent undergraduate degree in microbiology/molecular biology. Research experience or a post-graduate qualification in molecular biology would be an advantage. The programme is in cooperation with Otago University, Department of Microbiology, but is based at AgResearch, Lincoln. As a successful candidate your experience will have well equipped you with: ·good basic knowledge of microbiology and molecular biology; ·basic laboratory experience in bacteriology/molecular biology; ·excellent initiative, problem solving and communications skills. You will thrive in a team environment, and be highly motivated. AgResearch has a commitment to support ongoing training and continued professional development. The successful candidate will join our Microbial Control team of 20, based at our Lincoln campus, and be part of the Lincoln Centre of Research Excellence for Bioprotection, headquartered at neighbouring Lincoln University. The successful candidate can look forward to a competitive stipend, a supportive work environment and family friendly policies, as well as the lifestyle benefits of Canterbury - a relaxed region extending from the mountains to the sea with exceptional recreational activities and a low cost of living. A stipend to support a PhD student is available for 3 years.
(New Zealand-South Island-Christchurch) To assist in development of these growing fields we are seeking an energetic and innovative Technician to assist the microbiology/molecular biology research programme of our team. You will have an appropriate undergraduate degree in microbiology/molecular biology. Further laboratory experience would be an advantage. As a successful candidate your experience will have well equipped you with: ·good basic knowledge of microbiology and molecular biology; ·laboratory experience in bacteriology/molecular biology; ·good experimental skills (careful recording and reporting); ·excellent initiative, problem solving and communications skills. You will thrive in a team environment, and be highly motivated. AgResearch has a commitment to support ongoing training and continued professional development. The successful candidate will join our Microbial Control team of 20, based at our Lincoln campus, and be part of the Lincoln Centre of Research Excellence for Bioprotection, headquartered at neighbouring Lincoln University. The successful candidate can look forward to a competitive salary, a supportive work environment and family friendly policies, as well as the lifestyle benefits of Canterbury - a relaxed region extending from the mountains to the sea with exceptional recreational activities and a low cost of living.
(New Zealand-South Island-Christchurch) To assist in development of these growing fields we are seeking an energetic and innovative Research Associate to assist the molecular biology research programme of our team. You will have an appropriate undergraduate degree with experience in bacterial molecular biology including cloning, PCR, Southern, northern and western analyses. Experience in proteomics would be useful. A post-graduate qualification in molecular biology would be an advantage. As a successful candidate your experience will have well equipped you with: ·detailed knowledge of bacterial molecular biology; ·laboratory experience in molecular biology techniques; ·excellent experimental skills (design, recording and reporting); ·excellent initiative, problem solving and communications skills. You will have specialist knowledge for your position, thrive in a team environment, and be highly motivated. AgResearch has a commitment to support ongoing training and continued professional development. The successful candidate will join our Microbial Control team of 20, based at our Lincoln campus, and be part of the Lincoln Centre of Research Excellence for Bioprotection, headquartered at neighbouring Lincoln University. The successful candidate can look forward to a competitive salary, a supportive work environment and family friendly policies, as well as the lifestyle benefits of Canterbury - a relaxed region extending from the mountains to the sea with exceptional recreational activities and a low cost of living. This is a full-time, permanent position.
(New Zealand-South Island-Christchurch) To assist in development of these growing fields we are seeking and energetic and innovative Research Associate to assist the entomology/bioactives discovery research programme of our team. You will have an appropriate undergraduate degree in microbiology, zoology or entomology with experience in bioassays, insect physiology studies and/or histology. As a successful candidate your experience will have well equipped you with: ·detailed knowledge of insect morphology, physiology and histology; ·laboratory experience in bioassay and histology techniques; ·excellent experimental skills (Design, recording and reporting); ·excellent initiative, problem solving and communications skills. You will have specialist knowledge for your position, thrive in a team environment, and be highly motivated. AgResearch has a commitment to support ongoing training and continued professional development. The successful candidate will join our Microbial Control team of 20, based at our Lincoln campus, and be part of the Lincoln Centre of Research Excellence for Bioprotection, headquartered at neighbouring Lincoln University. The successful candidate can look forward to a competitive salary, a supportive work environment and family friendly policies, as well as the lifestyle benefits of Canterbury - a relaxed region extending from the mountains to the sea with exceptional recreational activities and a low cost of living. This is a full-time, permanent position.
(New Zealand-South Island-Christchurch) To assist in development of these growing fields we are seeking an energetic and innovative Post Doctoral researcher to carry out research within our team on the theme of Optimising production of biocontrol microbes. You will have an appropriate PhD and research experience in bioprocessing technologies. Experience in aerobic fermentation, process development and production optimization are required. As a successful candidate your experience will have well equipped you with: ·expert knowledge of bioprocessing technologies; ·experience with fermentation and large scale production of micro-organisms; ·excellent writing skills and the ability to produce papers acceptable to top international science journals; ·excellent initiative, problem solving and communications skills. You will have specialist knowledge for your position, thrive in a team environment, and be highly motivated. AgResearch has a commitment to support ongoing training and continued professional development. The successful candidate will join our Microbial Control team of 20, based at our Lincoln campus, and be part of the Lincoln Centre of Research Excellence for Bioprotection, headquartered at neighbouring Lincoln University. The successful candidate can look forward to a competitive salary, a supportive work environment and family friendly policies, as well as the lifestyle benefits of Canterbury - a relaxed region extending from the mountains to the sea with exceptional recreational activities and a low cost of living. The position is for a fixed term of two years.
(New Zealand-South Island-Christchurch) To assist in development of these growing fields we are seeking an energetic and innovative Post Doctoral researcher to carry out research within our team on the theme of Cellular response to microbial toxins. You will have an appropriate PhD and research experience in eukaryotic molecular and insect cell biology. Experience in insect cell structure and function and previous research with cell cultures would be an advantage. As a successful candidate your experience will have well equipped you with: ·expert knowledge of cell biology and cell physiology; ·experience with cell physiology and molecular biology techniques; ·excellent writing skills and the ability to produce papers acceptable to top international science journals; ·excellent initiative, problem solving and communications skills. You will have specialist knowledge for your position, thrive in a team environment, and be highly motivated. AgResearch has a commitment to support ongoing training and continued professional development. The successful candidate will join our Microbial Control team of 20, based at our Lincoln campus, and be part of the Lincoln Centre of Research Excellence for Bioprotection, headquartered at neighbouring Lincoln University. The successful candidate can look forward to a competitive salary, a supportive work environment and family friendly policies, as well as the lifestyle benefits of Canterbury - a relaxed region extending from the mountains to the sea with exceptional recreational activities and a low cost of living. The position is for a fixed term of two years.
(New Zealand) To assist in development of these growing fields we are seeking an energetic and innovative Post Doctoral researcher to carry out research within our team on the theme of Microbial response to stress. You will have an appropriate PhD and research experience in bacterial cell physiology and biochemistry with expertise in quantification of cell components (proteins, sugars, lipids) and an understanding of physiological response to stress. As a successful candidate your experience will have well equipped you with: ·knowledge of microbiology, cell physiology, cell biology; ·experience in molecular biology techniques; ·excellent writing skills and the ability to produce papers acceptable to top international science journals; ·excellent initiative, problem solving and communications skills. You will have specialist knowledge for your position, thrive in a team environment, and be highly motivated. AgResearch has a commitment to support ongoing training and continued professional development. The successful candidate will join our Microbial Control team of 20, based at our Lincoln campus, and be part of the Lincoln Centre of Research Excellence for Bioprotection, headquartered at neighbouring Lincoln University. The successful candidate can look forward to a competitive salary, a supportive work environment and family friendly policies, as well as the lifestyle benefits of Canterbury - a relaxed region extending from the mountains to the sea with exceptional recreational activities and a low cost of living. The position is for a fixed term of two years.
