
Clinical Trial News
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RTP’s Chimerix Begins Clinical Trials On Drug To Treat Multiple Infections
MyNC.com
Jan 6 2009, 3:02 pm
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Clinical Trials Update: Jan. 6, 2009
HealthDay via Yahoo! News
Jan 6 2009, 11:01 am
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Molecular Insight Into The Workings Of A Heart Failure Drug In Clinical Trials
Medical News Today
Jan 6 2009, 9:13 am
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Pediatric Research: Kids win when hospitals join forces on clinical trials
The Columbus Dispatch
Jan 6 2009, 2:41 am
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Clinical Trials Update: Jan. 5, 2009
HealthCentral
Jan 6 2009, 1:35 am
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M2S, Inc. Acquires DXA Resource Group; Expands Core Capabilities in Clinical Trial Image Management
PRWeb via Yahoo! News
Jan 6 2009, 1:05 am
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YM BIOSCIENCES RECEIVES CLEARANCE TO INITIATE RANDOMIZED DOUBLE-BLIND CLINICAL TRIALS OF NIMOTUZUMAB IN LUNG CANCER ...
CNW Group via Yahoo! Finance
Jan 5 2009, 4:00 pm
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Careers
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Director of Clinical Operations (Regional) |
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Careers
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Summary: The Regional Director of Clinical Operations is responsible for setting up and maintaining a regional network of experienced research investigators. In addition, he/she must effectively coordinate all aspects of project management across all clinical departments and interact as needed with operational staff to establish operational metrics, benchmark performance and duties associated with the evaluation, initiation, management and conduct of clinical trials. Requirements: - Develop and maintain a regional network of experienced clinical investigators in one or more therapeutic areas.
- Identify, hire, train and mentor clinical research coordinators in the regional network
- Provide business development support (e.g. new sponsor studies, sponsor presentations) to the Chief Business Development Officer to ensure corporate objectives are met.
- Provide excellent leadership, managerial, interpersonal and communication skills to facilitate and foster a cooperative work environment amongst all departments
- Establish effective communication with all departments: patient recruitment and marketing, regulatory and quality assurance on project related issues as required
- Oversee the coordination of projects to ensure they are conducted in an effective manner to maximize sponsor objectives and expectations while adhering to appropriate industry regulations, policies, procedures and quality standards.
- Prepare reports for regional network: budgets, expenses, and projections
- Review QA/QC reports and determine implementation of new policies as needed
- Ensure process and communication between teams is optimal
- Organize, oversee and complete special programs as directed by Corporate Officers
- Coach and mentor Managers
- Provide timely and accurate communication of key projects and issues/events to the Executive Management team
- Help identify and develop instructional programs and/or resources needed to accomplish regional and corporate operational goals.
- Oversee corporate contract deliverables and collaborate with other departments to include Business Development in preparation of change(s) when necessary
- Manage project finances including monthly reconciliation of finance/project reports
- Set Quarterly Project Goals for Senior Operations Managers
- Work Closely with Operations and Business Development to set priorities
Qualifications: - Must possess 8+ years healthcare industry and clinical research management experience
- Must be well organized, detail-oriented, multi-tasked and time-efficient.
- Must have the ability to network with physicians and other healthcare providers
- Must be a self starter and have good financial acumen.
- Must be knowledgeable with GCP guidelines as well as federal and state regulations.
- Must have demonstrated ability to lead and manage people and projects, possess strong communication, collaboration and interpersonal skills, and have the ability to work effectively with staff, peers and corporate officers.
Reports To: - Chief Operations Officer and/or Chief Business Development Officer
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Clinical Research Coordinator |
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Careers
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Description: ClinicAid Research Management, located in Southern California, is a rapidly growing research consortium providing CRO services for oncology clinical investigators. Due to unmet medical need, oncology is one of the fastest expanding markets for clinical trials, and new drugs in this area can improve the survival rates for cancer patients. Oncology research offers the most challenging AND rewarding career for qualified research coordinators. We are currently seeking EXPERIENCED Clinical (Trials) Research Coordinators (CRCs) to join our rapidly growing organization. Positions are available at our clinical sites in Corona and San Diego California for qualified applicants. These will initially be long term contract positions that may lead to full time employment within the organization. Opportunities may develop for career advancement in several areas within the organization. Only EXPERIENCED coordinators (minimum 1 year clinical research experience) should apply. ClinicAid is an equal opportunity employer. Requirements: Successful applicants must have a MINIMUM ONE YEAR experience performing the following duties: - Coordinating Phase I-IV clinical research trials.
- Training and experience in GCP, ICH, HIPAA, FDA Regulations, and SOPs.
- Experience in regulatory document processing (1572, IRB submissions, etc.) and reporting of (S)AEs. Familiarity with CRFs and ICFs.
- Ability to consult with study participants about study purpose and obtain informed consent.
- Efficiency in communicate with office staff for scheduling patients visits
- Ability to interact with physicians and actively recruit patients into the trials
- Ability to dispense study medications and track drug accountability
- Willingness to attend national investigator meetings as required
- Proficiency in organizing, evaluating, and reporting study data
- Coordinating monitoring visits with Sponsor personnel, designee, and study team
- Experience in participating in pre-qualification site and site initiation visits.
- Leadership in educating all staff regarding study design and time lines.
- Ability to develop and maintain enrollment plans and adjust recruitment strategies as necessary.
- Actively ensures timely and accurate transcription of data from the source document to the subject CRFs.
Qualifications: - Professional degree (B.A., R.N., etc) with at least 1 year of clinical trials research experience
- Preference given to applicants with experience in oncology trials
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Regulatory Affairs Specialist |
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Careers
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Description: ClinicAid Research Management, located in Southern California, is a rapidly growing research corporation providing Clinical Research services for health providers (doctors, academic centers, regional medical centers) and biopharma developers in multi-therapeutic markets. The R&D and clinical trial market continues to evolve and expad creating numerous opportunities for individuals passionate about a career in drug developmenth and biopharma. ClinicAid offers the most challenging AND rewarding career for qualified applicants. We are currently seeking EXPERIENCED Regulatory Affairs Specialists (RAS) to join our rapidly expanding operations. Positions are available at our national and international offices. All appointments will initially be long term contract positions that may lead to full time employment opportunities within the corporation. Opportunities may develop for career advancement in several areas within the organization. Only applicants with at least 1 year clinical research experience and three or more years of consecutive employment need apply. ClinicAid is an equal opportunity employer. Requirements: Successful applicants must have a MINIMUM ONE YEAR full time experience performing the following duties: - Preparing regulatory documents for submission to sponsor and IRB.
- Modify patient consent forms to include standard inserts.
- Submit new study information to appropriate scheduling, data entry, and recruiting staff.
- Monitor approval status and update study staff.
- Submit protocol amendments, updates to Investigator Drug Brochures, consent changes, and advertising to IRB.
- Assist coordinators in submitting the correct serious adverse event report forms to the IRB for all SAE’s occurring at our site.
- Revise 1572 forms as needed.
- Maintain current curriculum vitaes and medical licenses for all investigators and staff members.
- Gather financial disclosure questionnaires for all investigators and submit to the sponsor/CRO.
- Maintain pertinent laboratory licenses, CLIA, and lab normal value criteria.
- Obtain confidentiality agreements and CV’s from potential investigators.
- Complete and submit continuing reviews, final reports, and COV reports.
- Maintains regulatory research files, updates contact lists and other administrative records.
- Assure regulatory packages meet internal and/or agency submission timelines.
- Liaise with and be primary contact of regulatory bodies and specific clients.
Qualifications: - Professional degree (B.A., R.N., etc) with at least 1 year of clinical trials research experience
- Preference given to applicants with experience in oncology trials
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