SrCRA - Clintec position - Sponsor dedicated, Bonus 5000$ alla firma!
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.
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
• High School Diploma or equivalent Degree in scientific discipline or health care preferred.
• Requires at least 4 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
"Teamwork is an essential part of Clintec. We work together to meet deadlines and deliver work to the highest standard. The company has expanded since I started, so there are many opportunities arising within the Clinical Operations team. Clintec definitely offers a challenging and rewarding working environment where success is recognized amongst all employees."Clinical Research Associate, United Kingdom
"At Clintec, I feel I have been listened to and had my career goals and dreams fulfilled."Global Resourcing Executive, Australia
"I started Clintec with the knowledge that there are real opportunities for career progression. I’ve now experienced this firsthand."HR Advisor and Analyst, United Kingdom
"I am enjoying my career journey with Clintec. Clintec leads by example and has enormous and rewarding opportunities for employees."Senior Clinical Research Associate, Kingdom of Saudi Arabia
"I am relatively new to Clintec, and my first impression of the company is that we are treated as a family. There is a healthy working environment which fosters camaraderie among the team. I am looking forward to experiencing more growth, success, milestones with the Clintec family!"Clinical Operations Manager, Philippines
"There are so many great things about working at Clintec. I value the working relations I have with the Clintec employees. There is always an open opportunity to change career paths and the flexibility within the company is so refreshing. It is understandable why so many Clintec employees invest in a long career with this company. Clintec’s outstanding company culture and values allow for all employees to feel as though they belong. Clintec provides the opportunity to work for the best CRO in the industry."Clinical Operations Manager, South Africa
"I have finally found a company that sees my talent, uses my skills appropriately and wants me to grow! I have the opportunity to expand my horizons in a fast-growing company and take my team to new heights. It’s a great feeling to be with a company, a team, a family that allows me to have a happy, healthy, work-life balance and encourages both!"Clinical Operations Manager, USA
"Clintec is not an ordinary company where senior management is distant and just visible at conferences or our corporate brochures or webpage. We are growing fast but they still know how important it is to keep their feet on the ground regarding communication with the core of the company, its staff. I joined and was welcomed from day one. I’m proud to be a Scot in Europe representing the best Clintec values to potential new members of the company."Senior Global Resourcing Executive, Germany
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