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!
Experienced 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). 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 Clinical Operations Manager (COM) oversight.
Experienced 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). 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 Clinical Operations Manager (COM) oversight**
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
Provide applicable updates for site-related documentation for filing in the Trial Master File (TMF) and review collected documents for quality in accordance with Good Documentation Practice (GDP) and Worldwide Clinical Trials 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 close-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 (EDC) systems CRFs for completion, logic checks, and compliance with data entry requirements
Assist sites in resolution of Data Management (DM)-issued EDC queries and vendor-issued queries
Pull reports from study-specific portals and EDC systems, create or maintain study-specific trackers, and provide information to CTM for distribution to or use by the project team or sponsor
Provide visit preparation support for field CRAs, including routine summarization and communication of items such as action items, protocol deviations, EDC 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 access management for site staff (request and revoke access)
Support sites with prescreening, screening, and recruitment
Assist with subject eligibility review tracking and provide support to the Medical Monitor, as applicable and budgeted
May serve as the main point of contact for operational aspects for clinical research trials, as applicable
Provide mentoring and training for In-house Clinical Research Associate I and II
Attend and present updates during study meetings, if required
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.
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) Directive regulations, International Council for Harmonisation (ICH) guidelines, and local regulatory requirements, with training provided by Worldwide Clinical Trials
Good understanding of standard operating procedures, with training provided by Worldwide Clinical Trials
Basic knowledge of Microsoft Office
Familiarity with Interactive Voice Response System (IVRS) and electronic Case Report Form (eCRF) systems, with training provided by Worldwide Clinical Trials
Your experience:
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) 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 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.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all 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 when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, 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
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!
Experienced 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). 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 Clinical Operations Manager (COM) oversight.
Experienced 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). 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 Clinical Operations Manager (COM) oversight**
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
Provide applicable updates for site-related documentation for filing in the Trial Master File (TMF) and review collected documents for quality in accordance with Good Documentation Practice (GDP) and Worldwide Clinical Trials 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 close-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 (EDC) systems CRFs for completion, logic checks, and compliance with data entry requirements
Assist sites in resolution of Data Management (DM)-issued EDC queries and vendor-issued queries
Pull reports from study-specific portals and EDC systems, create or maintain study-specific trackers, and provide information to CTM for distribution to or use by the project team or sponsor
Provide visit preparation support for field CRAs, including routine summarization and communication of items such as action items, protocol deviations, EDC 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 access management for site staff (request and revoke access)
Support sites with prescreening, screening, and recruitment
Assist with subject eligibility review tracking and provide support to the Medical Monitor, as applicable and budgeted
May serve as the main point of contact for operational aspects for clinical research trials, as applicable
Provide mentoring and training for In-house Clinical Research Associate I and II
Attend and present updates during study meetings, if required
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.
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) Directive regulations, International Council for Harmonisation (ICH) guidelines, and local regulatory requirements, with training provided by Worldwide Clinical Trials
Good understanding of standard operating procedures, with training provided by Worldwide Clinical Trials
Basic knowledge of Microsoft Office
Familiarity with Interactive Voice Response System (IVRS) and electronic Case Report Form (eCRF) systems, with training provided by Worldwide Clinical Trials
Your experience:
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) 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 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.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all 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 when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, 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