In-House Clinical Research Associate
To see similar active jobs please follow this link: Remote Healthcare jobs
Are you passionate about supporting the successful execution of clinical trials and ensuring the development of life-changing therapies? At WEP Clinical, we are dedicated to helping patients gain early access to innovative treatments. We offer a collaborative environment where your contributions are valued, and we provide opportunities for both professional growth and personal fulfillment. Join our team as an In-House Clinical Research Associate and play a key role in advancing medical research while making a real impact on patients' lives!
Role Objectives:
The WEP Clinical In-House Clinical Research Associate (In-House CRA) coordinates aspects of clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA/MHRA/EMA guidelines, local regulations and WEP Clinical Standard Operating Procedures.
The In-House CRA provides operational support to ensure the effective and efficient delivery of clinical site monitoring and regulatory requirements as well as manages required documentation.
The In-House CRA will be a part of a multi-disciplinary team that provides scientific, statistical, operational, and support for clinical trials and Expanded Access Programs (EAP).
The Ideal Candidate:
Team Player
Detail Oriented
Problem Solver
Adaptable
What You'll Do:
Support the project team in the feasibility and site process, including collecting relevant data and tracking site feasibility progress.
Schedule and ensure on-site or remote monitoring visits (Investigator Meetings (IM), Qualification Visits (QV), Site Initiation Visit (SIV), Interim Monitoring Visit (IMV), and Close Out Visit (COV)) occur in accordance with project timelines and requirements.
Facilitating or scheduling site trainings required per study protocol.
Support the development of required documentation such as protocols, informed consent forms, case report forms.
Support the development of required monitoring related documentation such as Monitoring Plans, Visit Reports, Confirmation Letters, Follow-Up Letters, and Action Item Logs.
Coordinate with sites to resolve queries, actions items, data discrepancies and protocol deviations.
Ensure accurate documentation and reporting of safety events according to protocol and regulatory requirements.
Ensure timely, consistent and maintenance of Trial Master File for monitoring related documents.
Ensure timely, consistent and maintenance of Clinical Trial Management System for monitoring related activities.
Address protocol or monitoring related questions received from sites for assigned programs.
Proactively identifies and communicates site performance and monitoring issues to key stakeholders and implements action plans in conjunction with the project team.
Perform miscellaneous job-related duties as assigned.
What You'll Need:
2+ years’ experience in project management, clinical trials, and/or clinical research, (or equivalent combination of education, experience, and expertise)
Bachelor’s degree (in a science, nursing, pharmaceutical or related field preferred)
Computer literacy and proficient in Microsoft Office
Strong organizational skills and attention to detail
Positive attitude and ability to interact with all levels of staff to coordinate and execute project activities
Ability to manage multiple priorities
Effective verbal and written communication skills
What We Offer:
Medical, dental, and vision insurance, FSA, HSA
Voluntary short-term and long-term disability insurance
Voluntary life insurance
401K safe harbor plan and company match
Paid vacation, holiday, and sick time
Paid maternity & paternity leave
What sets us apart:
WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We're Committed to Our Team:
WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.
We're Committed to DEI:
At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.
Our services include:
Expanded Access Programs (EAPs)
Named Patient Programs (NPPs)
Clinical Trial Supplies (Comparator & Ancillaries)
Wren Nursing (Clinical Trial Home Nursing & Clinical Education)
Hospital Supply of Unlicensed Medicines
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
#LI-CG1
#LI-Remote
About the job
In-House Clinical Research Associate
To see similar active jobs please follow this link: Remote Healthcare jobs
Are you passionate about supporting the successful execution of clinical trials and ensuring the development of life-changing therapies? At WEP Clinical, we are dedicated to helping patients gain early access to innovative treatments. We offer a collaborative environment where your contributions are valued, and we provide opportunities for both professional growth and personal fulfillment. Join our team as an In-House Clinical Research Associate and play a key role in advancing medical research while making a real impact on patients' lives!
Role Objectives:
The WEP Clinical In-House Clinical Research Associate (In-House CRA) coordinates aspects of clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA/MHRA/EMA guidelines, local regulations and WEP Clinical Standard Operating Procedures.
The In-House CRA provides operational support to ensure the effective and efficient delivery of clinical site monitoring and regulatory requirements as well as manages required documentation.
The In-House CRA will be a part of a multi-disciplinary team that provides scientific, statistical, operational, and support for clinical trials and Expanded Access Programs (EAP).
The Ideal Candidate:
Team Player
Detail Oriented
Problem Solver
Adaptable
What You'll Do:
Support the project team in the feasibility and site process, including collecting relevant data and tracking site feasibility progress.
Schedule and ensure on-site or remote monitoring visits (Investigator Meetings (IM), Qualification Visits (QV), Site Initiation Visit (SIV), Interim Monitoring Visit (IMV), and Close Out Visit (COV)) occur in accordance with project timelines and requirements.
Facilitating or scheduling site trainings required per study protocol.
Support the development of required documentation such as protocols, informed consent forms, case report forms.
Support the development of required monitoring related documentation such as Monitoring Plans, Visit Reports, Confirmation Letters, Follow-Up Letters, and Action Item Logs.
Coordinate with sites to resolve queries, actions items, data discrepancies and protocol deviations.
Ensure accurate documentation and reporting of safety events according to protocol and regulatory requirements.
Ensure timely, consistent and maintenance of Trial Master File for monitoring related documents.
Ensure timely, consistent and maintenance of Clinical Trial Management System for monitoring related activities.
Address protocol or monitoring related questions received from sites for assigned programs.
Proactively identifies and communicates site performance and monitoring issues to key stakeholders and implements action plans in conjunction with the project team.
Perform miscellaneous job-related duties as assigned.
What You'll Need:
2+ years’ experience in project management, clinical trials, and/or clinical research, (or equivalent combination of education, experience, and expertise)
Bachelor’s degree (in a science, nursing, pharmaceutical or related field preferred)
Computer literacy and proficient in Microsoft Office
Strong organizational skills and attention to detail
Positive attitude and ability to interact with all levels of staff to coordinate and execute project activities
Ability to manage multiple priorities
Effective verbal and written communication skills
What We Offer:
Medical, dental, and vision insurance, FSA, HSA
Voluntary short-term and long-term disability insurance
Voluntary life insurance
401K safe harbor plan and company match
Paid vacation, holiday, and sick time
Paid maternity & paternity leave
What sets us apart:
WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We're Committed to Our Team:
WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.
We're Committed to DEI:
At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.
Our services include:
Expanded Access Programs (EAPs)
Named Patient Programs (NPPs)
Clinical Trial Supplies (Comparator & Ancillaries)
Wren Nursing (Clinical Trial Home Nursing & Clinical Education)
Hospital Supply of Unlicensed Medicines
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
#LI-CG1
#LI-Remote