Clinical Research Coordinator II - Beth Israel Lahey Health
Burlington, MA
About the Job
Job Type: Regular
Time Type: Full time
Work Shift: Day (United States of America)
FLSA Status: Non-Exempt
When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.
Job Description:
Clinical Research Coord II -
Under minimal supervision and direction will be responsible for the coordination and administration of multiple research studies. Responsible for assigned research studies and general research duties. Implements study protocols in accordance to regulatory and institutional requirements. Works closely with principal investigators, research staff and Research Administration facilitating all aspects of assigned clinical trials. Interacts with study participants diagnosed with various medical conditions and diagnoses.
Essential Duties & Responsibilities including but not limited to:
1) Possesses ongoing knowledge of FDA, OHRP and GCP regulations:
Ensures adherence to regulations. Educates and mentors other study staff as applicable.
2) Responsible for coordinating different phases of research studies with varying degrees of complexity with minimal oversight.
3) Implements assigned research studies by reviewing study and assessing protocol and institutional requirements.
4) Conducts assigned research studies per protocol requirements, departmental and institutional policy.
5) Recruits patients to assigned research studies. Works closely with physicians to develop recruitment strategies.
6) Performs Data Management duties: Prepares for each study participant visit to ensure all appropriate study procedures are done per protocol; ensures patient visit/test is billed correctly to either insurance or the research account per schema.
7) Maintains a professional relationship with sponsors and/or CRO’s and related members:
8) Works in collaboration with research finance on all study related finances including clinical trial agreements, budget preparation, patient related study visits, invoicing and helping to resolve study subject billing issues.
Minimum Qualifications:
Education :
Bachelor’s degree required; Master's degree preferred.
In absence of a Bachelor’s degree, will consider 6 years of relevant work experience in addition to the experience noted below.
Licensure, Certification & Registration:
None required.
Experience :
5+ years direct work-related experience in a research setting.
Skills, Knowledge & Abilities:
+ Ability to demonstrate basic knowledge of fundamental concepts, practices and procedures with the ability to use them in varied situations;
+ Ability to make decisions that are guided by general instructions and practices requiring some interpretation;
+ Seeks assistance when confronted with difficult and/or unpredictable situations;
+ Ability to travel nationally to other research sites, attend investigator meetings and educational conferences as required;
+ Strong verbal and written communication, multi-tasking, attention to detail and organizational skills;
+ Ability to interact with professional personnel at all levels and to communicate clearly and effectively;
+ Ability to demonstrate a positive attitude and respond to requests in a timely and respectful manner;
+ Ability to function independently, set priorities, provide clear direction and training, take initiative and work collaboratively in small teams;
+ Ability to interact with study participants with various diseases compassionately and respectfully;
+ Working knowledge of medical terminology and medical practice protocols;
+ Experience with computer systems, including web-based applications;
+ In the absence of any of these skills, demonstrates the ability to be thoroughly trained to meet organizational standards.
As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment. Learn more (https://www.bilh.org/newsroom/bilh-to-require-covid-19-influenza-vaccines-for-all-clinicians-staff-by-oct-31) about this requirement.
More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.
Equal Opportunity Employer/Veterans/Disabled
Time Type: Full time
Work Shift: Day (United States of America)
FLSA Status: Non-Exempt
When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.
Job Description:
Clinical Research Coord II -
Under minimal supervision and direction will be responsible for the coordination and administration of multiple research studies. Responsible for assigned research studies and general research duties. Implements study protocols in accordance to regulatory and institutional requirements. Works closely with principal investigators, research staff and Research Administration facilitating all aspects of assigned clinical trials. Interacts with study participants diagnosed with various medical conditions and diagnoses.
Essential Duties & Responsibilities including but not limited to:
1) Possesses ongoing knowledge of FDA, OHRP and GCP regulations:
Ensures adherence to regulations. Educates and mentors other study staff as applicable.
2) Responsible for coordinating different phases of research studies with varying degrees of complexity with minimal oversight.
3) Implements assigned research studies by reviewing study and assessing protocol and institutional requirements.
4) Conducts assigned research studies per protocol requirements, departmental and institutional policy.
5) Recruits patients to assigned research studies. Works closely with physicians to develop recruitment strategies.
6) Performs Data Management duties: Prepares for each study participant visit to ensure all appropriate study procedures are done per protocol; ensures patient visit/test is billed correctly to either insurance or the research account per schema.
7) Maintains a professional relationship with sponsors and/or CRO’s and related members:
8) Works in collaboration with research finance on all study related finances including clinical trial agreements, budget preparation, patient related study visits, invoicing and helping to resolve study subject billing issues.
Minimum Qualifications:
Education :
Bachelor’s degree required; Master's degree preferred.
In absence of a Bachelor’s degree, will consider 6 years of relevant work experience in addition to the experience noted below.
Licensure, Certification & Registration:
None required.
Experience :
5+ years direct work-related experience in a research setting.
Skills, Knowledge & Abilities:
+ Ability to demonstrate basic knowledge of fundamental concepts, practices and procedures with the ability to use them in varied situations;
+ Ability to make decisions that are guided by general instructions and practices requiring some interpretation;
+ Seeks assistance when confronted with difficult and/or unpredictable situations;
+ Ability to travel nationally to other research sites, attend investigator meetings and educational conferences as required;
+ Strong verbal and written communication, multi-tasking, attention to detail and organizational skills;
+ Ability to interact with professional personnel at all levels and to communicate clearly and effectively;
+ Ability to demonstrate a positive attitude and respond to requests in a timely and respectful manner;
+ Ability to function independently, set priorities, provide clear direction and training, take initiative and work collaboratively in small teams;
+ Ability to interact with study participants with various diseases compassionately and respectfully;
+ Working knowledge of medical terminology and medical practice protocols;
+ Experience with computer systems, including web-based applications;
+ In the absence of any of these skills, demonstrates the ability to be thoroughly trained to meet organizational standards.
As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment. Learn more (https://www.bilh.org/newsroom/bilh-to-require-covid-19-influenza-vaccines-for-all-clinicians-staff-by-oct-31) about this requirement.
More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.
Equal Opportunity Employer/Veterans/Disabled
Source : Beth Israel Lahey Health
