DIA On the Go eLearning Programs

DIA offers many eLearning programs that can help you advance your knowledge in the areas of clinical trials, drug safety, drug development, medical communications, and more.

For the clinical research professional, DIA offers the Clinical Trial Fundamentals eLearning Program, which is DIA's newest program is designed to provide a practical context to help clinical research professionals learn more about conducting clinical trials.

For more information on DIA's eLearning programs, please visit their site at diaglobal.org.

DIA 2016, A Gathering of Global Proportions

Don't miss DIA 2016, being held this year at the Pennsylvania Convention Center (Philadelphia, PA), June 26-30. This is a unique opportunity to interact with a number of diverse professionals and is packed with 175+ educational offerings on today's hottest topics. DIA 2016 brings together key thought leaders and innovators from industry, academia, government, and regulatory agencies, health, patient, and philanthropic organizations from around the globe.

FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond

This activity explains how U.S. public health policy has influenced and shaped the Food and Drug Administration (FDA) protections that Americans have come to expect, provides an overview of FDA’s Center for Drug Evaluation and Research, or CDER’s, role in the regulation of new drug development, marketed drugs, quality testing, and post-market surveillance, and identifies new directions for the human drug regulatory process in the United States.

Click here for course information: http://fdadrugregulations.e-paga.com

CTA

Advanced Clinical

Posted: January 15, 2016

Job ID: 143

Job Summary

Term: Contract
Job Roles: Other
Therapeutic Experience: Other
Required Education: Bachelor’s degree, BS preferred
Required Experience: 2 years
Compensation: hourly

Job Description

osition Summary:
The Clinical Trial Assistant provides clinical trial management support to the study team and is responsible for the development and maintenance of the Trial Master File.

Essential Functions:
• Collect, review for accuracy, and file essential documents in the Trial Master File
• Review and track essential documents such as informed consent documents, IRB approvals, financial disclosure forms, and other study-related documents for the project/study team.
• Assist in study start up activities including but not limited to review of sample Informed Consents and Investigator Essential Document Packages.
• Serve as central contact of the study team in study-related communications, documentation, and correspondence
• Assist in the distribution and tracking of clinical trial materials (CTM), such as study-related documents and equipment
• Cultivate and maintain excellent working relationships with study vendors, including Contract Research Organizations (CROs); assist and work with vendors to accomplish study timelines and goals
• Assist in the coordination and organization of clinical meetings such as team meetings, Investigator Meetings, and Data Safety Monitoring Board (DSMB) meetings as applicable, including scheduling, agendas, minutes, etc.
• Provide accurate and up-to-date information and study status reports to the clinical team members
• Perform other duties in support of Clinical Operations, as requested.

Preferred Qualifications:
• Minimum 2 years’ experience in clinical development.
• Bachelor’s degree, BS preferred
• Excellent communication, interpersonal, and organizational skills: ability to multi-task, prioritize, track projects, and follow-through on-time with assigned tasks, ability to work quickly and accurately in a fast-paced environment while paying strict attention to detail, ability to work independently and as part of a team.
• Proficient in computer and software skills (Outlook, Excel, Word, and PowerPoint).
• Ability to learn quickly and effectively use newly acquired skills.

Mohammad Ouranos| Clinical Recruiter
Advanced Clinical
570 Pacific Ave, San Francisco, CA 94133
M 949-836-3439
mouranos@advancedclinical.com
www.linkedin.com/in/mohammadouranos/
www.advancedclinical.com

Be Advanced. Advanced solutions for a better clinical experience.

Referrals are crucial to our success and we offer a referral bonus, from $1000 to $3000, should we successfully deploy someone you introduce.

Look up active jobs on our website & email me the job order # directly! http://www.advancedclinical.com/find-a-job

Senior Clinical Research Associate (Sr CRA)

Advanced Clinical

Posted: January 15, 2016

Job ID: 142

Job Summary

Term: Contract
Job Roles: Other
Therapeutic Experience: Other
Required Education: BS degree in a life science or related field
Required Experience: 3 years
Compensation: hourly

Job Description

Member of the clinical team responsible for conducting Phase I - IV studies according to Federal Regulations and ICH guidelines and study protocol, including planning study conduct, writing study protocols, designing CRFs, CRO selection, CRO training and management, selections and training of study investigators, planning and running study meetings, and overseeing the evaluation, selection and training of new study investigators. Responsible for the initial budget and contract negotiations with study sites or CROs. Responsible for writing and supervision of contributors of clinical reports and NDA documents, including integrated Summaries of Safety and Efficacy (ISS and ISE), as appropriate. 0-3 Years Experience Level.
- planning study conduct, writing study protocols, designing CRFs, CRO selection, CRO training and management, selections and training of study investigators, planning and running study meetings, and overseeing the evaluation, selection and training of new study investigators. Responsible for the initial budget and contract negotiations with study sites or CROs.

• Manage all operational study parameters including, but not limited to, clinical study start-
up activities, clinical supplies preparation, enrollment, data collection, and study budgets.
• Supervise monitoring activities of study data verification on source documentation and
case report forms (CRFs) to ensure compliance with the study protocols, GCPs, and
SOPs; Ensure data discrepancies are identified and resolved
• Prepare and oversee all study-related clinical documents including, but not limited to,
informed consent forms, site training materials, CRFs, clinical monitoring plans, source
document templates, and data audit worksheets
• Co-monitor on-site monitoring visits, including site qualification, initiation, interim, co-
monitoring with CRO, and close-out visits as necessary
• Up to 25% travel expectation, domestic
• BS degree in a life science or related field
• Experience as a Clinical Research Associate or similar role
• Medical device, biotech or pharmaceutical research experience
• Extensive experience in the preparation, monitoring, and execution of clinical studies
• 3 to 4 years of successful, wide-ranging experience managing contract research
organization (CRO) team members and study sites, including study start-up through study
maintenance and close out, with a demonstrated understanding of the data management
components needed in a trial, including enrollment projections, management and
• Superb verbal and written communication skills
• Excellent organizational skills along with strong attention to detail
• Ability to work both independently and collaboratively with cross-functional teams
• Highly proficient with Microsoft Office Suite
• Ability to utilize critical thinking to analyze problems which may require multiple factors
• Experience in a start-up or early stage company environment
• Experience in electrophysiology or cardiovascular preferred
• Project and people management experience

Mohammad Ouranos| Clinical Recruiter
Advanced Clinical
570 Pacific Ave, San Francisco, CA 94133
M 949-836-3439
mouranos@advancedclinical.com
www.linkedin.com/in/mohammadouranos/
www.advancedclinical.com

Be Advanced. Advanced solutions for a better clinical experience.

Referrals are crucial to our success and we offer a referral bonus, from $1000 to $3000, should we successfully deploy someone you introduce.

Look up active jobs on our website & email me the job order # directly! http://www.advancedclinical.com/find-a-job

Sr CRA

Advanced Clinical

Posted: January 15, 2016

Job ID: 141

Job Summary

Term: Contract
Job Roles: Independent Contractor/Consultant, Other
Therapeutic Experience: Other
Required Education: Degree
Required Experience: 4+ years
Compensation: per hour, w2 or 1099

Job Description

(Non-Oncology trials)

Sr. CRA to help out on both a single site trial at Standford and a multi-site trial for a Small Sponsor (small team). Contract will be written in 6 month blocks. Please let connect to discuss some of the details we are not able to list online.
We have other sponsors with similar needs so lets connect so I am able to have a good understanding of your experience to better assist you.

Mohammad Ouranos| Clinical Recruiter
Advanced Clinical
570 Pacific Ave, San Francisco, CA 94133
M 949-836-3439
mouranos@advancedclinical.com
www.linkedin.com/in/mohammadouranos/
www.advancedclinical.com

Be Advanced. Advanced solutions for a better clinical experience.

Referrals are crucial to our success and we offer a referral bonus, from $1000 to $3000, should we successfully deploy someone you introduce.

Look up active jobs on our website & email me the job order # directly! http://www.advancedclinical.com/find-a-job

Clinical Program Manager/AD

Advanced Clinical

Posted: January 15, 2016

Job ID: 139

Job Summary

Term: Full-Time
Job Roles: Other
Therapeutic Experience: Oncology
Required Education: Minimum BA/BS
Required Experience: 4+ years
Compensation: salary

Job Description

Hi,
Hope you are doing well. Please review the job opportunity below and contact me if you are interested or may know of someone interested.
Thank you in advance.

Advanced Clinical is a global, clinical outsourcing organization built around delivering a truly better clinical trial experience. We have a great job opportunity for a Clinical Program Manager/Associate Director to work within one of our Oncology Sponsors in Pleasanton, CA:

The Clinical Program Manager will be responsible for overseeing all aspects of the clinical program. This role will partner with the Clinical Operations staff and other departments to ensure that clinical trials are conducted in accordance with corporate Standard Operating Procedures (SOPs) and Guidelines, Good Clinical Practices (GCP), ICH Guidelines and applicable federal and national regulations (FDA and EMEA).

Responsibilities:
• Day-to-day management of clinical studies within assigned program; site selection, study implementation, management of CROs/vendors, ongoing management of study sites either directly or via service providers
• Organize and lead internal clinical study team meetings, and represent the Clinical Study Team at Project Team meetings
• Coordinate and/or participate in Investigator meetings, site initiation visits, and co-monitoring
• Train study coordinators and investigators on Good Clinical Practice/ICH and processes
• Prepare Investigator Brochures, manuscripts, safety, interim, and final study reports
• Participate in forecasting study drug supply requirements and managing logistics, budget planning and tracking, and development of best practices for Phase 1-3 study management
• Determine methods and procedures for new assignments with minimal supervision
• Proactively minimize risks
• Exercise sound judgment within defined practices and policies for selecting methods, techniques, and evaluation criteria resulting in clinical data of the highest quality
• Implement/innovate new processes for program or assigned studies within a program
• Travel: Up to 25%

Qualifications:
• Minimum BA/BS in a relevant scientific discipline
• Minimum 8 years’ clinical trial experience managing Phase 1 through 3 global studies in the oncology pharmaceutical industry
• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCP governing the conduct of routine clinical trials
• Ability to plan, prioritize, and accomplish goals within timelines
• Ability to develop tools and processes that result in increased efficiencies
• Ability to manage responsibilities and resolve complex problems with minimal guidance
• Strong team player and facilitator; ability to incorporate needs from cross-functional areas
• Detail-oriented with meticulous follow-through in a fast-paced environment
• Exceptional oral, written, interpersonal, and presentation skills
• Proficiency using Microsoft Office

Please let me know your salary requirements, we can discuss it once we connect. They would like to stay at 155K if possible.

Please email me your resume/CV to mouranos@advancedclinical.com and let me know when you have time to discuss the position over the phone.

Referrals are crucial to our success and we offer a referral bonus, from $1000 to $3000, should we successfully deploy someone you introduce.
Thank you,

Mohammad Ouranos| Clinical Recruiter
Advanced Clinical
570 Pacific Ave, San Francisco, CA 94133
M 949-836-3439
mouranos@advancedclinical.com
www.linkedin.com/in/mohammadouranos/
www.advancedclinical.com

Be Advanced. Advanced solutions for a better clinical experience.

Referrals are crucial to our success and we offer a referral bonus, from $1000 to $3000, should we successfully deploy someone you introduce.

Look up active jobs on our website & email me the job order # directly! http://www.advancedclinical.com/find-a-job

Alliance for Clinical Research Excellence and Safety (ACRES)

The Alliance for Clinical Research Excellence and Safety (ACRES) is a global collaborative model, which aims to transform the clinical research enterprise through the construction of a global system for clinical research to accelerate medicines development while enhancing quality, safety, and long-term industry sustainability.

Educational Tools and Resources from CISCRP

CISCRP is an affiliate and partner of ACRP and is a 12-year-old non-profit organization dedicated to engaging the public and patients as partners in the clinical research process. CISCRP provides a variety of award-winning resources, programs, and services.

ACRP Members now enjoy exclusive discounts on educational tools and resources provided by the Center for Information & Study on Clinical Research Participation (CISCRP). These resources are great for helping trial sites educate study volunteers and to show appreciation for the role they play in advancing public health.

Biostatistics for Non-Statisticians

The Center for Professional Innovation and Education is featuring a course designed as an introduction to the statistical principles that form the basis for the design and analysis of research investigations in pharmaceutical and medical device studies. The focus of topics will benefit individuals within the pharmaceutical, biotech and device industries including R & D managers, medical investigators, basic and clinical research scientists, clinical research associates and those involved in regulatory affairs.

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