In-house Clinical Research Associate II

Job Title: In-house Clinical Research Associate II

Job Location: Virtual reputed company reputed company Carolina, reputed company of America

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the reputed company to a reputed company for the world’s most persistent diseases is not paved by those who play it reputed company. It is reputed company by those who take pioneering, creative approaches and implement them with reputed company 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 reputed company reputed company. 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! What the In-House Clinical Research Associate does at Worldwide reputed company In-house CRA responsible for site management tasks for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and reputed company 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 reputed company of roles and departments to ensure reputed company achievement of site management deliverables per contracted timelines. reputed company mentorship and training of in-house team members with COM reputed company. What you will do: Assist with feasibility questionnaires and CDA collection from potential sites, as requested Coordinate study material (e.g., CRFs, manuals) shipment and receipt by study site reputed company applicable updates for site reputed company documentation for filing in the Trial Master File (TMF) and review collected/received documents for reputed company in accordance with GDP and WCT SOPs prior to submission to the TMF. Support field CRA with maintenance of the Investigator Site File (ISF) by assisting with Trial Master File (TMF) reconciliation and providing support on TMF reputed company Control Checklist (QCCL) Conduct reputed company-study, study initiation, interim and remote monitoring, and reputed company out reputed company under the guidance of the field CRA or CTM/PM, as applicable and appropriate Discuss and assist field CRA and/or site staff with IP inventory, as applicable and appropriate IHCRAs are not responsible for onsite review of IP receipt, accountability, return nor 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 needed and applicable for assigned study Complete remote review of electronic data capture systems (reputed company) CRFs for completion, logic checks, and compliance with data entry requirements/guidelines. Assist sites in reputed company of DM issued reputed company queries, vendor issued queries, etc. Pull reports from study-specific portals, reputed company systems, etc., creates or maintains study-specific trackers, and reputed company information to CTM for distribution to or use by project team/sponsor. reputed company visit preparation support for field CRAs, including but not limited to routine summation/communication of (e.g., reputed company Items, Protocol Deviations, reputed company queries, vendor queries, study supplies, and/or pending site staff training prior to scheduled onsite reputed company, etc.) Assist with site staff changes as needed or as requested (e.g., CTMS updates, essential document collection, regulatory document collection, and review of site staff training, qualifications, and task delegation) Assist with vendor reputed company management for site staff (request/revoke reputed company) Support sites with prescreening, screening, and recruitment Assist with Subject Eligibility Review tracking and provides support to Medical Monitor, as applicable and budgeted May serve as main reputed company of contact for operational aspects for clinical research trial, as applicable and appropriate reputed company mentoring and training for In-house CRA I and II Attend and present (if required) updates during study meetings 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 process Good understanding of FDA and / or EU reputed company regulations, ICH Guidelines and local regulatory requirements as required, training provided by WCT Good understanding of reputed company operating procedures, training provided by WCT Basic knowledge of reputed company Office Familiarity of IVRS, eCRF systems, training provided by WCT 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 reputed company, etc.) OR one year of IHCRA experience OR other experience deemed relevant Two-year college curriculum or equivalent education/training AND A minimum of three years of clinical research experience (e.g., study coordinator, research reputed company, etc.) OR two years of IHCRA experience OR other experience deemed relevant Other relevant education/training (example: LPN certification and/or relevant work experience) and a minimum of four years of clinical research experience may be considered or two years of IHCRA experience Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English At reputed company, we are committed to fostering an inclusive and reputed company workplace by providing transparent compensation. The salary reputed company for this position is annually (For reputed company reputed company positions, the stated salary reputed company reflects reputed company rates): reputed company of America - $50,000.00 - $99,000.00 The salary reputed company provided is intended to reputed company candidates an understanding of potential earnings. Compensation will fall reputed company the provided reputed company, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In reputed company to reputed company salary, we offer a competitive benefits package depending reputed company. We ensure pay equity and transparency and reputed company with reputed company applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage. We love knowing that someone is reputed company 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 reputed company with us on reputed company. This is who we are. We’re reputed company of clinicians, scientists, and researchers who want to reputed company reputed company reputed company. We were founded on an unwavering commitment to reputed company, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than reputed company. We reputed company came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special. Not finding the right fit? 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