Client Dedicated Senior CRA
Found in: Resume Library US A2 - 1 week ago
Monitors investigator sites with a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable
Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM).
Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Contributes to the project team by mentoring new members, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements share potential solutions for improvements.
Performs additional tasks as assigned by CTM or Clinical Manager of CRAs (CMCRA) (e.g. trip report review, newsletter creation, lead CRA team calls etc).
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Perform QC check of reports generated from CTMS system where required.
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections federal regulatory requirements/audits.
Maintains completes administrative tasks such as expense reports and timesheets in a timely manner.
Keys to Success:
Education and Experience:
Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years as a clinical research monitor).
Valid driver's license where applicable. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Effective clinical monitoring skills
Excellent understanding and demonstrated application of FDA guidelines, ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
Manages Risk Based Monitoring concepts and processes · Ability to mentor and train other monitors in a positive and effective manner · Ability to evaluate medical research data and proficient knowledge of medical terminology
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers underlying issues
Excellent interpersonal skills · Strong attention to detail
Effective organizational and time management skills
Ability to remain flexibile and adaptable in a wide range of scenarios Excellent team player with team building skills
Ability to work independently as required
Ability to utilize problem-solving techniques applicable to constantly changing environment
Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
Effective presentation skills.
Please use the below link for job application and quicker response.
-
Full Time Family Medicine Physician
Found in: beBee jobs US - 1 week ago
Greenacres City, Florida, United States Dedicated Senior Medical Center Full timeFor seniors most in need of care, high quality health care is too often beyond reach. Dedicated Senior Medical Center a ChenMed Company is a national leader in value-based, primary care that was founded to bring concierge-style medicine — and better health outcomes — to the neediest populations. ChenMed is a senior focused primary care organization, in...
-
Senior Client Relationship Manager
Found in: beBee jobs US - 1 week ago
California, United States William Blair Full timeWilliam Blair Investment Management is committed to building enduring relationships with our clients. We work closely with private and public pension funds, insurance companies, endowments, foundations, and sovereign wealth funds, as well as financial advisors. We are 100% active-employee-owned with broad-based ownership. Our investment teams are solely...
-
(Senior) In-House CRA
1 week ago
Oklahoma City, United States FUTRUE Full timeÜber uns FUTRUE ist mehr als ein international ausgerichteter Healthcare-Konzern! Mit mittlerweile über 20 Unternehmen und mehr als 70 Arzneimittelzulassungen sind wir u.a. in den Bereichen intelligente Bakterien, innovative Schmerztherapien sowie chemiefreie Arzneimittel weltweit führend. Zahlreiche unserer Unternehmen, darunter z.B. SYNformulas oder...
-
Tax Senior Manager | Private Client
7 days ago
Kansas City, United States FORVIS Full timeDescription & Requirements FORVIS Private Client tax advisors provide sophisticated tax compliance, consulting, and planning services to individuals, multi-generational families, fiduciaries, and more. Our professionals include CPAs and JDs. The Tax Senior Manager serves as a trusted advisor and member of various client service teams and must possess...
-
Senior Quality Assurance Consultant
1 week ago
Oklahoma City, United States Rbw Consulting Full timeAre you a detail-oriented QA professional with a deep understanding of Good Clinical Practice (GCP) guidelines? If so, I want to hear from you! We are partnered with a breaking clinical biotech company seeking a highly motivated Senior QA Consultant to join their growing team. What you'll do: Conduct comprehensive reviews of clinical trial protocols,...
-
Senior Manager, Client Services
18 hours ago
Foster City, United States Zoox, Inc. Full timeFoster City, CA / Information Technology Network Services & Client Support / Full-time/ Hybrid. As a Senior Manager of the Client Services team you will provide strategic guidance to the team supporting the future growth of Zoox. You will create an Client Service, Manager, Information Technology, Client Support, Senior, User Experience, Automotive
-
Senior Financial Analyst
Found in: Resume Library US A2 - 2 weeks ago
Foster City, California, United States Visa Full timeJob Description This is a unique opportunity that calls for a motivated, hard-working, and highly analytical Finance professional to join the Client Services Global Finance team. This Senior Financial Analyst will support several businesses within the Client Services team with regards to in-depth business planning, reporting, business-case...
-
Senior Client Services Manager, Events
Found in: Resume Library US A2 - 2 weeks ago
Las Vegas, Nevada, United States GES Full timeOverview: The Senior Client Services Manager (Events) maintains and expands relationships with our key customers. Assigned to high profile, complex corporate events ranging from mid-to-large revenue, the Senior Client Services Manager (Events) is responsible for leading overall planning, budgeting, and execution while achieving key strategic objectives. They...
-
Kansas City, United States Senior Star Full time** Part-Time Shuttle Driver/Chauffer, Senior Living Community** **Job Category****:** PROGRAMS **Requisition Number****:** PARTT002938 Showing 1 location **Job Details** **Description** **VILLA VENTURA IS SEEKING A PART TIME DRIVER** **Responsible for providing transportation for residents and company sponsored community activities. At Senior Star the...
-
Senior Client Executive
16 hours ago
Redwood City, United States Equinix, Inc. Full timeBuild Customer Relationships Develops and maintains relationships with regional/global customer executives to drive global bookings/revenue growth Manages the engagement with the customer as a strategic alliance relationship, encompassing sell to, Executive, Solutions Architect, Sales Leader, Senior, Client, Sales Engineer, Transportation, Business Services
-
Director of Compliance
6 days ago
Kansas City, United States Armed Forces Bank Full timeThis position provides Executive leadership to the Compliance department for the DFC-owned banks. Will develop, implement, and administer all aspects of the banks compliance management program, including Compliance and CRA.Principal Accountabilities :Ensure that the regulatory compliance functions are developed and reviewed to stay abreast of changes in...
-
Senior Client Executive
17 hours ago
Redwood City, United States Equinix, Inc. Full timeWho are we? Equinix is the world's digital infrastructure company, operating over 250 data centers across the globe. Digital leaders harness Equinix's trusted platform to bring together and interconnect foundational infrastructure at software speed. Equinix enables organizations to access all the right places, partners and possibilities to scale with...
-
Senior Client Service Manager
Found in: Resume Library US A2 - 3 days ago
Fresno, California, United States Gallagher Full timeAbout Us: Welcome to Gallagher – a global leader in insurance, risk management, and consulting services. With a growing team of more than 45,000 professionals worldwide, we empower businesses, communities, and individuals to thrive. At Gallagher, you can build a career whether it’s with our brokerage division, our benefits and HR consulting division, or...
-
Director of Compliance
1 week ago
Kansas City, United States Armed Forces Bank Full timeThis position provides Executive leadership to the Compliance department for the DFC-owned banks. Will develop, implement, and administer all aspects of the banks’ compliance management program, including Compliance and CRA. Principal Accountabilities: Ensure that the regulatory compliance functions are developed and reviewed to stay abreast of...
-
Director of Compliance
1 week ago
Kansas City, United States Dickinson Financial Corporation Full timePosition DescriptionSummary: This position provides Executive leadership to the Compliance department for the DFC-owned banks. Will develop, implement, and administer all aspects of the banks' compliance management program, including Compliance and CRA. Principal Accountabilities: Ensure that the regulatory compliance functions are developed and reviewed...
-
Senior Civil Engineer
4 days ago
Nevada, United States CareerBuilder Full timeSenior Civil Engineer (Mining) Haley & Aldrich is a 900+ personnel national engineering and environmental consulting firm with creative, technically strong staff who want to work in a collaborative environment to deliver exceptional value to our clients. We look for professionals with a passion for solving even the most complex client problems. This...
-
Senior Business Analyst
Found in: beBee S US - 3 weeks ago
California City, United States Atechstar Full timeJob Description The Senior Business Analyst Education All GraduatesExperience (Years) 0 to 8Job Responsibilities Determine and document user / client requirements and abide by those requirements during the duration of the projects. Develop comprehensive test cases wherever applicable. Develop and maintain direct channels of communication with data...
-
Senior Trial Attorney
Found in: Jooble US O C2 - 1 week ago
California, United States Adamson Ahdoot LLP Full timeOverview: We are a plaintiff personal injury law firm specializing in substantial/catastrophic injuries based in Los Angeles and we are seeking a Senior Trial Attorney to join our team. The role will have the opportunity to handle quality and serious personal injury matters and lead the fight for our clients to achieve valuable settlements, verdicts,...
-
Administrative Assistant, Client Services
Found in: Resume Library US A2 - 4 days ago
Los Angeles, California, United States JAMS, Inc. Full timeOverview: JAMS is committed to diversity and inclusion. A Brief Overview Provides concierge service and administrative support to clients. Offers a high level of client service to internal and external clients. Maintains Resolution Center appearance and provides base-level case support. Responsibilities: What you will do Provides professional...
-
Senior Tax Accountant
Found in: Resume Library US A2 - 1 week ago
Merced, California, United States Stardom Employment Consultants Full timePosition: Senior Tax Accountant Company Overview: Stardom Employment Consultants LLC is a leading staffing and recruitment agency based in Merced, CA. We specialize in providing top-notch talent to businesses in various industries, including finance, accounting, and tax. Job Overview: We are seeking an experienced Senior Tax Accountant to join our...