Senior Clinical Research Associate 3793
2 weeks ago
This is a contract job opportunity
Position: Senior Clinical Research Associate 3793
Projected duration: 6 months
Job code:CVDJP00023793
- Site monitoring responsibility for clinical studies according to Standard Operating Procedures, ICH Guidelines and GCP
- Site management responsibility for clinical studies according to Standard Operating Procedures, ICH Guidelines and GCP
- Assures the implementation of project plans as assigned
- Function as leader for projects of limited scope as assigned
- Assume line management responsibilities as assigned
- Act in the project role of a Local Project Coordinator or Lead CRA as assigned
**Essential Job Duties**:
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, asassigned
- Responsible for all aspects of site management as prescribed in the project plans
- General On-Site Monitoring Responsibilities:
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safelyenter patients into the study
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements areadhered to according to the applicable regulatory requirements
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
- Monitor data for missing or implausible data
- Ensure the resources of the Sponsor and are spent wisely by performing the
required monitoring tasks in an efficient manner, according to SOPs and established
guidelines, including managing travel expenses in an economical fashion according to travel policy
- Travel, including air travel, may be required and is an essential function of the
- Prepare accurate and timely trip reports
- Manage small projects under direction of a Project Manager/Director as assigned
- Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review asassigned
- Review progress of projects and initiate appropriate actions to achieve target objectives
- Organize and make presentations at Investigator Meetings
- Participate in the development of protocols and Case Report Forms as assigned
- Participate in writing clinical trial reports as assigned
- Interact with internal work groups to evaluate needs, resources and timelines
- Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
- Responsible for all aspects of registry management as prescribed in the project plans
- Undertake feasibility work when requested
- Conduct, report and follow-up on Quality Control Visits (CQC) when requested
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities,translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor asassigned
- Negotiate study budgets with potential investigators and assist the legal department with
statements of agreements as assigned
- Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Independently perform CRF review; query generation and resolution against established data review guidelines onor client data management systems as assigned by management
- Assist with training, mentoring and development of new employees, g. co-monitoring
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and mayact as a local client contact as assigned
- Perform other duties as assigned by management
**Minimum Required**:
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
AND
- a minimum of 4 years of Clinical Monitoring experience- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Advanced site monitoring skills
- Advanced study site management skills
- Advanced registry administration skills
- Ability to work with mínimal supervision
- Good planning and organizational skills
- Good computer skills with good working knowledge of a range of computer packages
- Advanced verbal and written communication skills
- Ability to train and supervise junior staff
- Ability to resolve project-related problems and prioritizes workload for self and team
- Ability to work within a project team
- Works efficiently and effectively in a matrix environment
**Preferred**:
- One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
- Local project coordination and/or project management
**
-
Clinical Research Associate
2 weeks ago
محافظة القاهرة, Egypt IQVIA Full time**Job Overview** Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. **Essential Functions** - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in...
-
Regulatory & Start Up Associate Consultant
2 weeks ago
محافظة القاهرة, Egypt IQVIA Full time**Job Overview** - Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. - ** Essential Functions**: - Ensure adherence to standard operating procedures (SOPs), Work...
-
Regulatory and Start Up Coordinator
2 weeks ago
محافظة القاهرة, Egypt IQVIA Full timeUnder general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. **Essential Functions** - Under general...
-
Ip Associate Human Resources Director
3 weeks ago
محافظة الإسماعيلية, Egypt Mennonite Central Committee Full timeOther, Other, International Location where MCC is registered Applications due: 04 Apr, 2025 **Job Synopsis** The International Program Associate Human Resources Director provides leadership to the human resource function of Mennonite Central Committee’s International Program (IP). This includes responsibility for and decision-making authority to develop...
-
Intern
4 weeks ago
محافظة القاهرة, Egypt IQVIA Full timeInternal Job Description **What we Offer**: - Insight into the most important phases of a clinical trial and CTA responsibilities - Experience working alongside Clinical Trials Assistants - Exposure to working in a challenging, international business environment - The opportunity to explore and advance your career in Clinical Research - Duration: 6 months....
-
Site Activation Specialist
4 weeks ago
محافظة القاهرة, Egypt IQVIA Full time**Job Overview** Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors;...
-
Senior Aquarist
5 days ago
محافظة الإسماعيلية, Egypt SEA LIFE Trust Full time**Senior Aquarist** Sealife Trust - Beluga Building Company ehf, Ægisgata 2, 900 Vestmannaeyjar, 900 Iceland **Key Responsibilities**: - Oversee the daily maintenance and care of aquatic animals in the aquarium - Develop and implement comprehensive animal care and maintenance programs that meet or exceed industry standards - Train and supervise a team of...
-
Product Designer
4 days ago
محافظة الإسماعيلية, Egypt DuckDuckGo Full timeHi, we're DuckDuckGo, the online protection company and remote-first team of 300+ on a mission to raise the standard of trust online. Founded in 2008 and profitable since 2014, annual revenue now exceeds $100m USD and millions use our browser on Mac, Windows, iOS, and Android, our search engine, and the latest — Privacy Pro. Our culture of trust,...
-
Plumber
2 weeks ago
محافظة الإسماعيلية, Egypt University of Sheffield Full timeThe Department of Estates and Facilities Management (EFM) at the University of Sheffield is responsible for the management of the University's estate including managing property and facilities and developing new buildings. We have a great opportunity in the Engineering & Maintenance team for someone with a passion for maintenance who is looking to make a...
-
Beirut - Senior Associate - Paid Search
2 weeks ago
محافظة الجيزة, Egypt Merkle Full timeCompany Description: Merkle is a leading data-driven, technology-enabled, global performance marketing agency that specialises in the delivery of unique, personalised customer experiences across platforms and devices. We call it ‘people-based’ marketing, and with over 25 years’ experience, we are proud to be recognised as a global leader. Merkle’s...
-
Site Activation Specialist
2 weeks ago
محافظة القاهرة, Egypt IQVIA Full time**Site Activation Specialist**:Grade 130 **Country Site Activation - CSA** IQVIA’s Country Site Activation team are a global network who identify and activate sites to the highest quality to ensure patients on Clinical trials have access to safe and effective medication. We are leaders in innovation and first to new technologies meaning a vast amount of...
-
Country Director
2 weeks ago
محافظة الإسماعيلية, Egypt ACR Globe Full timeCOUNTRY DIRECTOR BRIEF Country Directors represent their company in a foreign country. They work within growing industries experiencing global expansion. They manage all operations in a particular region, including recruitment, budgets, planning, and submitting reports. They might also require specialized skill sets and industry-related knowledge. -...
-
Senior Content Writer
2 weeks ago
محافظة الإسماعيلية, Egypt Plato HQ Full timeWe are the first ever Talent Growth platform. We are on a mission to help engineering and product leaders become great leaders. Thanks to our software, our talent coaching program and our incredible community we help thousands of aspiring leaders to grow. We started with external mentorship for engineering leaders and experienced exponential growth for the...
-
B2b Lead Generation Specialist
4 weeks ago
محافظة الدقهلية, Egypt KAIZEN Asset Management Services Full time**Job Summary**: **Responsibilities**: **Identify Target Market**: Research and identify the target market within the Owner Association and Property Management B2B sector. Understand the unique challenges, pain points, and needs of potential clients. **Prospecting and Qualification**: Conduct research and prospecting activities to identify key...
-
Senior Analyst, Maintenance
4 days ago
محافظة القاهرة, Egypt SC Johnson Full time**SC Johnson has the opportunity for an Senior Analyst, Maintenance** **ABOUT SC JOHNSON** SC Johnson is a fifth-generation family company built on a spirit of adventure and winning the right way. We have been leading with purpose for over 130 years, building top brands such as Raid®, Glade®, Kiwi®, OFF!®, Windex®, Ziploc® and more, in virtually...
-
Senior Product Designer
4 weeks ago
محافظة الجيزة, Egypt McLedger Full time**Company Description** We're a dynamic tech company at the forefront of transforming the SaaS Accounting software landscape in the Middle East. As the brains behind mazeed, we're on a mission to empower businesses with innovative solutions. Our team operates in a hybrid model, embracing remote work and collaboration at our Cairo branch office. **Job...
-
Fullstack Engineer
4 days ago
محافظة البحر الأحمر, Egypt Elves App Full time**Senior Full-Stack**: - Collaborate with all team members to architect, conceptualize, and ship new features regularly - Build and maintain API services - Typescript language proficiency - Experience with modern fullstack nodejs frameworks (next.js, nuxt.js, nest.js, koa,...etc) - Creating and managing Background jobs (trigger-based/scheduled) - e2e Test...
-
Senior Functional Safety Engineer
2 days ago
محافظة الدقهلية, Egypt Danfoss Full timeRequisition ID: 23822 Job Location(s): Graasten, DK Do you want to be in the driver seat for functional safety within Danfoss Drives! If you take the chance as our new Senior Functional Safety Engineer, you will get the opportunity to use your Systems Engineering skills and drive the development of functional safety of Danfoss Drives products. You will...
-
Senior Compliance Engineer
17 hours ago
محافظة الدقهلية, Egypt Danfoss Full timeRequisition ID: 26742- Job Location(s): Graasten, DKWould an internationally oriented position with both technical and interpersonal requirements appeal to you? And would you like to use your technical talent to ensure product approvals required worldwide before launch? Then you could be the new Senior Compliance Engineer we are looking for in Danfoss Drives...
-
Undergraduate Summer Internship
4 weeks ago
محافظة القاهرة, Egypt Bosch Group Full time**Company Description** Robert Bosch Egypt is a growing company of the Bosch Group located in Cairo, Egypt. We operate in the business divisions Automotive Aftermarket, Power Tools and Security Systems. At Bosch, we shape the future by inventing high-quality technologies and services that spark enthusiasm and enrich people’s lives. Our promise to our...