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 built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright 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.

We believe 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 all 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 thrive by being themselves and are inspired to do their best work every day.

Experienced In‑house CRA 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). Provide 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.

Provide mentorship and training of in‑house team members with COM oversight.

• 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
• Provide applicable updates for site related documentation for filing in the Trial Master File (TMF) and review collected/received documents for quality 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 Quality Control Checklist (QCCL)
• Conduct pre‑study, study initiation, interim and remote monitoring, and close out visits 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 (EDC) CRFs for completion, logic checks, and compliance with data entry requirements/guidelines.
• Assist sites in resolution of DM issued EDC queries, vendor issued queries, etc.
• Pull reports from study‑specific portals, EDC systems, etc., creates or maintains study‑specific trackers, and provide information to CTM for distribution to or use by project team/sponsor.
• Provide visit preparation support for field CRAs, including but not limited to routine summation/communication of (e.g., Action Items, Protocol Deviations, EDC queries, vendor queries, study supplies, and/or pending site staff training prior to scheduled onsite visits, 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 access management for site staff (request/revoke access)
• Support sites with prescreening, screening, and recruitment
• Assist with Subject Eligibility Review tracking and provides support to Medical Monitor, as applicable and budgeted
• May…