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.
Why Worldwide
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. Join us!
*SUMMARY: 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.
RESPONSIBILITIES:*
_Tasks may include but are not limited to:_
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 serve as main point of contact for operational aspects for clinical research trial, as applicable and appropriate
Provide mentoring and training for In-house CRA I and II
Attend and present (if required) updates during study meetings
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
*
OTHER SKILLS AND ABILITIES:*
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 Directive regulations, ICH Guidelines and local regulatory requirements as required, training provided by WCT
Good understanding of standard operating procedures, training provided by WCT
Basic knowledge of Microsoft Office
Familiarity of IVRS, eCRF systems, training provided by WCT
*REQUIREMENTS:*
A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science AND
A minimum of two years of clinical research experience (e.g., study coordinator, research nurse, etc.) OR one year of IHCRA experience OR other experience deemed relevant
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, etc.) OR two years of IHCRA experience OR other experience deemed relevant
OR
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
AND
Fluent in the local languages of the countries under responsibilities 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.
At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.
The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):
United States of America - $50,000.00 - $99,000.00
The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all 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 going to have a better life because of the work we do.
To view our other roles, check 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 LinkedIn.