Sr Clinical Research Associate
Company Name:
Lahey Health
Job Description
Coordinates multiple research studies by implementing study protocols in accordance with regulatory and institutional requirements. Sets up administrative systems to manage the progress of each study while screening, recruiting and educating patients and collecting and reporting study data. Maintains interdisciplinary relationships with participating physicians and clinical departments. Provides daily supervision, mentoring and training to Clinical Research Associates, and Study Coordinators.
Responsibilities
Essential Duties & Responsibilities including but not limited to:
1)Knowledge and experience in the implementation of all aspects of clinical trials research
2)Leads the clinical trial research team in all aspects of the implementation of clinical trials
3)Contacts and coordinates develops the multidisciplinary trial team
4)Develops support staff roles, alters roles as deemed necessary
5)Responsible for oversight of support staff
6)Implements training program for support staff
7)Assigns responsibility of new protocols to staff members
8)Develops sponsor contacts / relationships
9)Oversight of protocol preparation for IRB submission
10)Knowledge of FDA, OHRP and GCP regulations, assures adherence to regulations, educates study staff
11)Active participation in trial budget preparation
12)Works collaboratively with investigators to identify cost saving measures in relation to system/operational efficiencies
13)Site initiation activities coordination
14)Management of subjects via recruitment, protocol specific assessment of data collection
15)Education of study subjects / family members about requirements of the clinical trial
16)Maintain study drug Rx dispensing / device inventory logs
17)Coordination with study staff for preparation / participation in site monitoring visits / collaborative group audits
18)Assistance with investigator protocol development (when requested)
19)Responsible for regulatory submissions to IRB in a timely manner
20)Assurance that applicable adverse events are properly reported to the sponsor and IRB
21)Ensures quality of data reported
Qualifications
Minimum
Qualifications:
Education: Associates degree or equivalent work experience.
Licensure, Certification, Registration: N/A
Skills, Knowledge & Abilities: Strong orginizational and communication skills. Proven ability to provide clear supervision and training, to function independtly and to interact with professional personnel at all levels of an orgainzation. Working knowledge of medical terminology and medical practice protocols. Working knowledge knowledge of computer databases and word processing systems.
Experience: Minimum of 2 years experience working in an inpatient or outpatient clinical setting. Minimum of 6 months experience as a Clinical Research Associate or equivalent responsibilities.
Shift
DAYS, 8-5 Monday - Friday, schedule subject to change based upon the needs of the department.
About Lahey Health
At Lahey Hospital & Medical Center, as one of the world's premier health care organizations, we provide superior health care leading to the best possible outcome for every patient. We exceed our patients' high expectations for service each day. We also help advance medicine through research and the education of tomorrow's health care leaders
We care for our patients with compassion and openness, unsurpassed expertise, a drive for continuous learning improvement, and with respect, caring, teamwork, excellence and commitment to doing our personal best.
Join our team and our mission of excellence by applying today!
How To Apply
Once you have logged into Colleague Connection, click on 'Lahey Jobs' located at the bottom of the menu list. Once you have located the desired job, click on the checkbox in the 'Select' column, and then click the 'Apply Now' button, located at the bottom of the screen. Please note you are only able to select 5 jobs at a time
Company Description:
Lahey Health follows a different model of care that delivers clinical excellence close to home and is committed to helping our communities become and stay healthy. We provide integrated services and a continuum of care that includes award-winning hospitals, outpatient facilities, primary care providers, specialist physicians, behavioral health and senior care resources and services throughout northeastern Massachusetts and southern New Hampshire.
Lahey is a thriving organization that is passionate about patient satisfaction and quality outcomes within an environment that promotes teamwork and professional development.
Lahey Hospital & Medical Center is a nationally recognized, award winning, teaching and academic center. We employ more than 500 physicians and 5,000 nurses, therapists and support staff.Estimated Salary: $20 to $28 per hour based on qualifications.
Lahey Health
Job Description
Coordinates multiple research studies by implementing study protocols in accordance with regulatory and institutional requirements. Sets up administrative systems to manage the progress of each study while screening, recruiting and educating patients and collecting and reporting study data. Maintains interdisciplinary relationships with participating physicians and clinical departments. Provides daily supervision, mentoring and training to Clinical Research Associates, and Study Coordinators.
Responsibilities
Essential Duties & Responsibilities including but not limited to:
1)Knowledge and experience in the implementation of all aspects of clinical trials research
2)Leads the clinical trial research team in all aspects of the implementation of clinical trials
3)Contacts and coordinates develops the multidisciplinary trial team
4)Develops support staff roles, alters roles as deemed necessary
5)Responsible for oversight of support staff
6)Implements training program for support staff
7)Assigns responsibility of new protocols to staff members
8)Develops sponsor contacts / relationships
9)Oversight of protocol preparation for IRB submission
10)Knowledge of FDA, OHRP and GCP regulations, assures adherence to regulations, educates study staff
11)Active participation in trial budget preparation
12)Works collaboratively with investigators to identify cost saving measures in relation to system/operational efficiencies
13)Site initiation activities coordination
14)Management of subjects via recruitment, protocol specific assessment of data collection
15)Education of study subjects / family members about requirements of the clinical trial
16)Maintain study drug Rx dispensing / device inventory logs
17)Coordination with study staff for preparation / participation in site monitoring visits / collaborative group audits
18)Assistance with investigator protocol development (when requested)
19)Responsible for regulatory submissions to IRB in a timely manner
20)Assurance that applicable adverse events are properly reported to the sponsor and IRB
21)Ensures quality of data reported
Qualifications
Minimum
Qualifications:
Education: Associates degree or equivalent work experience.
Licensure, Certification, Registration: N/A
Skills, Knowledge & Abilities: Strong orginizational and communication skills. Proven ability to provide clear supervision and training, to function independtly and to interact with professional personnel at all levels of an orgainzation. Working knowledge of medical terminology and medical practice protocols. Working knowledge knowledge of computer databases and word processing systems.
Experience: Minimum of 2 years experience working in an inpatient or outpatient clinical setting. Minimum of 6 months experience as a Clinical Research Associate or equivalent responsibilities.
Shift
DAYS, 8-5 Monday - Friday, schedule subject to change based upon the needs of the department.
About Lahey Health
At Lahey Hospital & Medical Center, as one of the world's premier health care organizations, we provide superior health care leading to the best possible outcome for every patient. We exceed our patients' high expectations for service each day. We also help advance medicine through research and the education of tomorrow's health care leaders
We care for our patients with compassion and openness, unsurpassed expertise, a drive for continuous learning improvement, and with respect, caring, teamwork, excellence and commitment to doing our personal best.
Join our team and our mission of excellence by applying today!
How To Apply
Once you have logged into Colleague Connection, click on 'Lahey Jobs' located at the bottom of the menu list. Once you have located the desired job, click on the checkbox in the 'Select' column, and then click the 'Apply Now' button, located at the bottom of the screen. Please note you are only able to select 5 jobs at a time
Company Description:
Lahey Health follows a different model of care that delivers clinical excellence close to home and is committed to helping our communities become and stay healthy. We provide integrated services and a continuum of care that includes award-winning hospitals, outpatient facilities, primary care providers, specialist physicians, behavioral health and senior care resources and services throughout northeastern Massachusetts and southern New Hampshire.
Lahey is a thriving organization that is passionate about patient satisfaction and quality outcomes within an environment that promotes teamwork and professional development.
Lahey Hospital & Medical Center is a nationally recognized, award winning, teaching and academic center. We employ more than 500 physicians and 5,000 nurses, therapists and support staff.Estimated Salary: $20 to $28 per hour based on qualifications.
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