Medical University of South Carolina
UNIV - Clinical Research Coordinator I - Department of Medicine: Division of GI
Medical University of South Carolina, Charleston, South Carolina, United States, 29401
UNIV - Clinical Research Coordinator I - Department of Medicine: Division of GI
Charleston, South Carolina The candidate will assist the Principal Investigator and research team in the collection of research data, data entry, the recruitment of research participants, and miscellaneous organizational tasks for studies being conducted in the Department of Gastroenterology and Hepatology. The candidate will work primarily on research studies that focus on the study of and development of treatments for nonalcoholic steatohepatitis and other chronic liver diseases. The research assistant will be directly involved in the collection and organization of all study specific data that could include EDC, queries, questionnaires, interviews to assess inclusion/exclusion criteria, laboratory samples as required, and other research related tasks as required per protocol. Medical University of South Carolina (MUSC - Univ) Employee Research Grant CC000968 COM DOM Gastroenterology CC Hourly University-05 38,985.00 - 55,559.50 - 72,134.000 40 Job Duties: 35% - Serve as study coordinator in gastroenterology & hepatology clinical trials: Obtain informed consent, screen and enroll study patients, conduct study visits as per protocol, coordinate patient visits, provide education to subjects, monitor adverse events and prepare serious adverse event reports, collect and process lab samples, dispense study medication to patients, conduct patient diary reviews, enter data and complete case report forms, and maintain all study documents as required per protocol/study guidelines. 20% - Coordinate proper data management according to protocol requirements and compliance, i.e. collect and record all data pertaining to study subjects as required per specific study protocol. Provide study team support (update/maintain study trackers, create pre-screening logs for each study, maintain Oncore platform as required, schedule subject visits per protocol, meet with and support study monitors as required, update EDC and review for integrity as required). 20% - Assist with recruitment of research study patients for all protocols that are recruiting on an on-going basis (chart review, emails/calls to potential subjects). 15% - Collect and process lab samples that require specific training for each study. Order study kits as needed for each study, monitor study kits and shipping boxes for each lab utilized for current studies. 10% - Prepare for and conduct monitor and auditor visits for each study as required by sponsor, FDA, or internal audit. Schedule as needed and coordinate as needed. Additional Job Description Minimum Requirements: A bachelor's degree and two years of relevant program experience. Physical Requirements: Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.
Charleston, South Carolina The candidate will assist the Principal Investigator and research team in the collection of research data, data entry, the recruitment of research participants, and miscellaneous organizational tasks for studies being conducted in the Department of Gastroenterology and Hepatology. The candidate will work primarily on research studies that focus on the study of and development of treatments for nonalcoholic steatohepatitis and other chronic liver diseases. The research assistant will be directly involved in the collection and organization of all study specific data that could include EDC, queries, questionnaires, interviews to assess inclusion/exclusion criteria, laboratory samples as required, and other research related tasks as required per protocol. Medical University of South Carolina (MUSC - Univ) Employee Research Grant CC000968 COM DOM Gastroenterology CC Hourly University-05 38,985.00 - 55,559.50 - 72,134.000 40 Job Duties: 35% - Serve as study coordinator in gastroenterology & hepatology clinical trials: Obtain informed consent, screen and enroll study patients, conduct study visits as per protocol, coordinate patient visits, provide education to subjects, monitor adverse events and prepare serious adverse event reports, collect and process lab samples, dispense study medication to patients, conduct patient diary reviews, enter data and complete case report forms, and maintain all study documents as required per protocol/study guidelines. 20% - Coordinate proper data management according to protocol requirements and compliance, i.e. collect and record all data pertaining to study subjects as required per specific study protocol. Provide study team support (update/maintain study trackers, create pre-screening logs for each study, maintain Oncore platform as required, schedule subject visits per protocol, meet with and support study monitors as required, update EDC and review for integrity as required). 20% - Assist with recruitment of research study patients for all protocols that are recruiting on an on-going basis (chart review, emails/calls to potential subjects). 15% - Collect and process lab samples that require specific training for each study. Order study kits as needed for each study, monitor study kits and shipping boxes for each lab utilized for current studies. 10% - Prepare for and conduct monitor and auditor visits for each study as required by sponsor, FDA, or internal audit. Schedule as needed and coordinate as needed. Additional Job Description Minimum Requirements: A bachelor's degree and two years of relevant program experience. Physical Requirements: Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.