Manages all clinical aspects of study, including: assesses operational feasibility and recommends study execution plan; assist in developing and managing comprehensive Clinical study timelines and metrics; provides study-specific training and leadership to clinical research staff; prepares and presents project debriefings, as required; plans, executes, and leads study-specific meetings (e.g., Study Management Meetings, investigator meetings); participates in site monitoring visits as appropriate. Manages overall study recruitment campaigns and manages enrolment timelines
Uses operational and therapeutic expertise to optimize trial design and execution: works with the study team to design clinical protocol; provides input for the design of the ICF template, Source documents and CRFs
Prepares and/or reviews study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines). Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets).
Responsible for ensuring that Project Team delivers timely and satisfactory Project and Client Clinical deliverables
Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate
Management of all Clinical Trial Assistants (CTAs) and Clinical Monitors, to include coaching and providing guidance; Mentor the CTAs on the subjects of job performance, trainings and professional growth
Daily interaction with study Director, Clinical Services Branch and members of the cross-functional study team
Selects sites and countries; develops relationships with investigators and site staff
Lead the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., Regulatory Affairs, investigators, vendors, etc.)
Lead and partake in regular team meeting / teleconferences; Participate/present at Client Presentation Meetings as necessary; Participate/present at Investigator Meetings as necessary
Communicate any out of scope issues to upper management as soon as identified
Other duties as assigned
Bachelors Degree in biomedical sciences or related scientific discipline
8+ years of clinical research experience
Excellent verbal and written communication skills required
Excellent organizational, multi-tasking and time management skills required
Sound knowledge of medical terminology and clinical trial management process
Excellent verbal and written communications skills
Knowledge of FDA regulations and ICH guidelines
Excellent skills at documenting study conduct and management
Effective business skills for interactive situations with peers, sites and clients
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VIEW JOBS9/21/2018 12:00:00 AM2018-12-20T00:00<strong>Headquartered in Miami, Florida </strong>with<strong> offices and operations across Germany, USA, Russia, Ukraine, and India; </strong>Biorasi is<strong> an award-winning,</strong> fast growing, full-service, global CRO that delivers Clinical Research Optimized™ to the world's leading biotech and pharmaceutical companies. We are looking for a dynamic, forward-thinking “game changer” to join our QA team and promote a GCP / QA philosophy thru interactions with staff on a global level. We require an independent, confident, and highly motivated GCP / QA professional with extensive knowledge/experience of deviations, CAPA, process improvement (including SOP creation/revision), and audit experience to join our growing QA Team. They will conduct various types of internal and external audits of clinical research activities in support of global clinical trials (drug product and medical device), including monitoring quality assessments, TMF audits, project management audits, internal process audits, Clinical Study Report audits and supplier audits in any of the regions involved in Biorasi managed clinical trials. As a leader in the QA group at Biorasi, they will also participate in consultation and interpretation of regulations, development, implementation and content updates of Good Clinical Practices (GCP) and compliance training programs, identification and development of SOPs and Processes, proactive noncompliance issue identification, and escalation and management of CAPAs. <br />
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Direct report to the Head of Global Quality Assurance to ensure Biorasi quality systems, processes, and procedures are compliant with applicable regulations and ICH guidelines.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Assist in identifying needs and the planning of internal and vendor Quality Assurance audits.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Conduct internal, site, and vendor GCP/QA audits when directed.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Identify gaps, risks, and areas of continuous improvement within Biorasi’s quality systems, processes, and procedures.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Identification, initiation, follow up, and closure of deviations, CAPAs, and process improvements on a cross-functional level.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Communicate expectations and direction from Head of Quality to other Biorasi departments and locations to reduce compliance risks and improve global quality and consistency.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Bachelor Degree.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">At least 4 years CRO / GCP / QA experience.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Experience with auditing clinical vendors, investigator sites, and internal audits. (Audit travel up to 15%.) Auditing certification highly preferred.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Understanding of controlled documents, CAPAs, and Deviation Reports.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Practical knowledge of regulations and ICH guidelines with a focus on GCP, quality, and compliance.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Must be fluent in English, with superb attention to detail.</li>
VIEW JOBS9/19/2018 12:00:00 AM2018-12-18T00:00Clinical Dietitian
Aventura Hospital & Medical Center
Aventura Hospital is a fully accredited 407-bed acute care facility, providing award-winning inpatient and outpatient diagnostic, medical, surgical and cancer services. In order to meet the needs of our ever-growing community we have invested $130 million in expanding and renovating the hospital. The new North Patient Tower features 243 private rooms with private baths, the newest technologically advanced patient care equipment, a 28 bed-Emergency Department, 2 new ICU units, the Surgical Services Suite with 10 new oversized operating rooms, a new Main Entrance and much more.
Ideally located in luxurious South Florida, Aventura Hospital is home to a community rich with diversity and world class infused culture. Our prime location - nestled between Miami and Ft. Lauderdale - means you'll be surrounded by the very best South Florida has to offer!
Aventura Hospital & Medical Center is a member of the nation's leading provider of healthcare services, Hospital Corporation of America. HCA Ranks on Fortune's list of Most Admired Companies for three consecutive years. In addition, HCA has also been named one of Ethisphere's World's Most Ethical Companies for seven consecutive years. Join our tradition of excellence!
We offer a generous compensation package for Full-time and Part-time including: vacation, 401k, and Medical Insurance.
The Clinical Dietician works under the direction of the Clinical Nutrition Services Manager to ensure that patient's nutritional needs are met. Visits, screens and prioritizes patient care based on acuity level, affecting the nutritional care of patients. Assesses nutritional needs, develops and implements nutritional care, and evaluates and reports these results appropriately. Coordinates these activities with the department's management team, cooperating with other areas of the department. Serves as a role model for the department.
* Appropriately documents medical nutrition treatment plan in the patient's medical record indicating all pertinent data and information.
* Completes and documents patient education i.e. food drug interaction, nutrition counseling as appropriate in a timely manner.
* Demonstrate appropriate use of PPE with a thorough understanding of procedures to minimize exposure in keeping with the safety culture within the hospital.
* Takes on an active role in the reviewing / developing and or approving of the diet manual, patient menus, nutrition education materials related to patient care.
* Plans, implements, correlates and supervises all activities related to the total therapeutic diet program and the teaching related to therapeutic diets.
* Records nutritional progress notes concisely and accurate in the medical record in the SOAP format utilizing existing online documents.
* Degree in Human Nutrition or related area required
* Registered Dietitian certification required.
* 1 year of experience in healthcare nutrition management required.
* Ability to read, write, and converse in English.