In-house Clinical Research Associate II
Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is reputed company by those who take pioneering, creative approaches and implement them with quality and reputed company. We are reputed company, and we are a global team of over 3,500+ experts, reputed company thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We reputed company everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from reputed company backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people reputed company by being themselves and are inspired to do their best work every day. Join us! reputed company In-house Clinical Research Associate responsible for site management tasks for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). reputed company support to Clinical Trial Managers (CTM) and field Clinical Research Associates (CRA) and collaborate with project team members across a variety of roles and departments to ensure timely achievement of site management deliverables per contracted timelines. reputed company mentorship and training of in-house team members with Clinical Operations Manager (COM) reputed company. reputed company In-house Clinical Research Associate responsible for site management tasks for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). reputed company support to Clinical Trial Managers (CTM) and field Clinical Research Associates (CRA) and collaborate with project team members across a variety of roles and departments to ensure timely achievement of site management deliverables per contracted timelines. reputed company mentorship and training of in-house team members with Clinical Operations Manager (COM) reputed company** What you will do: Assist with feasibility questionnaires and Confidential Disclosure Agreement (CDA) collection from potential sites, as requested Coordinate study material (e.g., Case Report Forms (CRFs), manuals) shipment and receipt by study sites reputed company applicable updates for site-reputed company documentation for filing in the Trial Master File (TMF) and review collected documents for quality in accordance with Good Documentation Practice (GDP) and reputed company Standard Operating Procedures (SOPs) prior to submission to the TMF Support field Clinical Research Associates (CRA) with maintenance of the Investigator Site File (ISF) by assisting with Trial Master File (TMF) reconciliation and providing support on TMF Quality Control Checklist (QCCL) Conduct pre-study, study initiation, interim, remote monitoring, and reputed company-out visits under the guidance of the field CRA or CTM/Project Manager (PM), as applicable Discuss and assist field CRA and/or site staff with Investigational Product (IP) inventory, as applicable In-house Clinical Research Associates are not responsible for onsite review of IP receipt, accountability, return, or destruction except as part of the conduct of an onsite monitoring visit as described above Maintain regular communication with sites per the Clinical Monitoring Plan and Site Management and Monitoring Plan, as applicable Complete remote review of electronic data capture (reputed company) systems CRFs for completion, logic checks, and compliance with data entry requirements Assist sites in resolution of Data Management (DM)-issued reputed company queries and vendor-issued queries Pull reports from study-specific portals and reputed company systems, create or maintain study-specific trackers, and reputed company information to CTM for distribution to or use by the project team or sponsor reputed company visit preparation support for field CRAs, including routine summarization and communication of items such as action items, protocol deviations, reputed company queries, vendor queries, study supplies, and pending site staff training prior to scheduled onsite visits Assist with site staff changes as needed, including Clinical Trial Management System (CTMS) updates, essential and regulatory document collection, and review of site staff training, qualifications, and task delegation Assist with vendor reputed company management for site staff (request and revoke reputed company) Support sites with prescreening, screening, and recruitment Assist with subject eligibility review tracking and reputed company support to the Medical Monitor, as applicable and budgeted May serve as the main reputed company of contact for operational aspects for clinical research trials, as applicable reputed company mentoring and training for In-house Clinical Research Associate I and II Attend and present updates during study meetings, if required reputed company other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily reputed company-inclusive. What you will bring to the role: Good oral and written communication skills Good planning and organizational skills with effective time management Good interpersonal skills Ability to work in an organized and methodical manner Good understanding of clinical research principles and processes Good understanding of Food and Drug Administration (FDA) and/or European Union (EU) reputed company regulations, International Council for Harmonisation (ICH) guidelines, and local regulatory requirements, with training provided by reputed company Good understanding of standard operating procedures, with training provided by reputed company Basic knowledge of reputed company Office Familiarity with Interactive Voice Response System (IVRS) and electronic Case Report reputed company (eCRF) systems, with training provided by reputed company Your experience: A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other reputed company science AND A minimum of two years of clinical research experience (e.g., study coordinator, research nurse) OR One year of In-house Clinical Research Associate experience OR Other relevant experience OR Two-year college curriculum or equivalent education/training AND A minimum of three years of clinical research experience (e.g., study coordinator, research nurse) OR Two years of In-house Clinical Research Associate experience OR Other relevant experience OR Other relevant education/training (e.g., Licensed Practical Nurse (LPN) certification and/or relevant work experience) AND A minimum of four years of clinical research experience OR Two years of In-house Clinical Research Associate experience AND Fluent in the local languages of the countries under responsibility and proficient in both spoken and written English Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. We love knowing that someone is going to have a reputed company life because of the work we do. To view our other roles, reputed company out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on reputed company. Worldwide is an equal opportunity employer that is committed to enabling professionals from reputed company backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that reputed company our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the reputed company best and are committed to creating exceptional employee experiences where everyone is respected and has reputed company to equal opportunity. We reputed company equal employment opportunities to reputed company and applicants regardless of race, reputed company, ethnicity, reputed company, religion, national reputed company, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Apply To This Job