CenExel
Clinical Trial Manager
CenExel, Atlanta, Georgia, United States, 30383
About Us:
Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary:
Responsible for the management of clinical research studies and the personnel assigned to those studies, under the direction of the Clinical Director.
Essential Responsibilities and Duties:Manages all assigned clinical staff.Reads and understands assigned protocols and leads and interfaces on such protocols with the study staff to achieve successful execution within appropriate timeframes.Conducts Site Qualification Visits, as assigned. Schedules and oversees Investigator Meeting arrangements, conducts initiation, study start-up, and team meetings. Oversees scheduling and conduct of monitor visits. Represents the clinical team during site visits.Oversees preparation of, or personally prepares study-specific source documents for new protocols. Reviews and modifies sponsor-provided source documents, when necessary. Assists Study Coordinators in duties, as necessary.On assigned protocols, assists to oversee delivery, shipment, inventory, storage, calibration and accountability of investigational products, supplies and equipment required to conduct clinical investigations.Ensures optimum team function by assisting Clinical Research Coordinators with site start up, enrollment and study execution. Is present for first patient randomized on each study.Fields protocol questions from Clinical Research Coordinators.Acts as the project lead, liaising between sites, investigators, monitors, clinical research coordinators, physicians, laboratory, pharmacy staff, and other study team members. Assists with study in-services and other training needs as needed.Oversees the following aspect of trials but is not limited to: Vendors, Client Satisfaction, Recruitment, Quality, Study Start-up and Trial Outcomes.Monitoring the progress and completion of routine action items and ensuring timely follow-up.Ensuring proper internal procedures are followed and documentation is obtained from coordinators for approval of retest, unscheduled visits, admits, AE treatments, etc.Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.Education/Experience/Skills:
Bachelor's degree or equivalent experience preferred.Minimum of one-year Clinical Research Coordinator or equivalent experience.Ability to independently coordinate and manage complex protocols and to lead, motivate and train a clinical research team.Ability to communicate effectively, both verbally and in writing.Experience managing staff and implementing personnel procedures.Professional image, upholding the company vision in actions, demeanor, and appearance.Must be able to effectively communicate verbally and in writing.
Working ConditionsIndoor, Clinic and Office environment.Essential physical requirements include sitting, typing, standing, walking.Lightly active position, occasional lifting of up to 20 pounds.Reporting to work, as scheduled, is essential.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary:
Responsible for the management of clinical research studies and the personnel assigned to those studies, under the direction of the Clinical Director.
Essential Responsibilities and Duties:Manages all assigned clinical staff.Reads and understands assigned protocols and leads and interfaces on such protocols with the study staff to achieve successful execution within appropriate timeframes.Conducts Site Qualification Visits, as assigned. Schedules and oversees Investigator Meeting arrangements, conducts initiation, study start-up, and team meetings. Oversees scheduling and conduct of monitor visits. Represents the clinical team during site visits.Oversees preparation of, or personally prepares study-specific source documents for new protocols. Reviews and modifies sponsor-provided source documents, when necessary. Assists Study Coordinators in duties, as necessary.On assigned protocols, assists to oversee delivery, shipment, inventory, storage, calibration and accountability of investigational products, supplies and equipment required to conduct clinical investigations.Ensures optimum team function by assisting Clinical Research Coordinators with site start up, enrollment and study execution. Is present for first patient randomized on each study.Fields protocol questions from Clinical Research Coordinators.Acts as the project lead, liaising between sites, investigators, monitors, clinical research coordinators, physicians, laboratory, pharmacy staff, and other study team members. Assists with study in-services and other training needs as needed.Oversees the following aspect of trials but is not limited to: Vendors, Client Satisfaction, Recruitment, Quality, Study Start-up and Trial Outcomes.Monitoring the progress and completion of routine action items and ensuring timely follow-up.Ensuring proper internal procedures are followed and documentation is obtained from coordinators for approval of retest, unscheduled visits, admits, AE treatments, etc.Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.Education/Experience/Skills:
Bachelor's degree or equivalent experience preferred.Minimum of one-year Clinical Research Coordinator or equivalent experience.Ability to independently coordinate and manage complex protocols and to lead, motivate and train a clinical research team.Ability to communicate effectively, both verbally and in writing.Experience managing staff and implementing personnel procedures.Professional image, upholding the company vision in actions, demeanor, and appearance.Must be able to effectively communicate verbally and in writing.
Working ConditionsIndoor, Clinic and Office environment.Essential physical requirements include sitting, typing, standing, walking.Lightly active position, occasional lifting of up to 20 pounds.Reporting to work, as scheduled, is essential.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.