Medical University of South Carolina
UNIV - Research Program Coordinator II - Sugery: Clinical Trials
Medical University of South Carolina, Charleston, South Carolina, United States, 29401
Program Coordinator II
The Program Coordinator II is responsible for conducting all aspects of clinical drug and device trials; patient data; and disease registries for the Department of Surgery and the Department of Urology as directed by the Principal Investigator. This person will also conduct all research in adherence with the FDA Code of Federal Regulations, "Good Clinical Practices", and adhere to the MUSC IRB regulations for the protection of human subjects. Entity: Medical University of South Carolina (MUSC - Univ) Worker Type: Employee Worker Sub-Type: Research Grant Cost Center: CC001076 COM Urology CC Pay Rate Type: Salary Pay Grade: University-06 Pay Range: $47,588.00 - $67,817.00 - $88,047.000 Scheduled Weekly Hours: 40 Work Shift: Job Description: Pay Range: $46,655.00 - $66,488.00 - $86,321.00 (min - mid - max) Job Duties: Manage day to day clinical trial operations. Submissions to IRB to be prepared according to regulations and deadlines including: applications, renewal, adverse events, write informed consent document and amendments, protocol amendments. Case Reports Forms and source documentation to be completed and maintained accurately, truthfully, and timely. Obtain informed consent under the direction of the Principle Investigator and maintain accurate informed consent documents for later review. Ensure study-required clinical elements and tests are conducted and collected according to the protocol. Train staff on various aspects of conducting clinical trials. Serve as an expert resource on conducting clinical trials and mentor to junior staff. Call responsibilities on a rotational basis with other research personnel in the department. Will be a resource for all clinical needs and available to answer study related questions or talk with patients about study participation. Design and implement department wide tools necessary to conduct clinical trials in the necessary clinical settings; inpatient units, O.R., outpatient clinic, laboratory, radiology etc. Design and implement tools for the department in regards to IP. Review Sponsor protocols and make recommendations as to the feasibility of conducting a particular trial at our center given the available resources and patient population. Also, make recommendations for necessary protocol changes prior to accepting a protocol. Negotiate ongoing and new budgets. Travel to Sponsor initiated investigator meetings with investigator to review protocols for initiation and to review clinical findings during a trial as needed. Prepare for and conduct monitor and auditor visits for each study as required by sponsor, FDA or internal auditing. Serve as an expert resource for creating and implementing corrective action plans. Additional Job Description: Minimum Requirements: A bachelor's degree and two years of relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) 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) If you like working with energetic enthusiastic individuals, you will enjoy your career with us! 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. Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.
The Program Coordinator II is responsible for conducting all aspects of clinical drug and device trials; patient data; and disease registries for the Department of Surgery and the Department of Urology as directed by the Principal Investigator. This person will also conduct all research in adherence with the FDA Code of Federal Regulations, "Good Clinical Practices", and adhere to the MUSC IRB regulations for the protection of human subjects. Entity: Medical University of South Carolina (MUSC - Univ) Worker Type: Employee Worker Sub-Type: Research Grant Cost Center: CC001076 COM Urology CC Pay Rate Type: Salary Pay Grade: University-06 Pay Range: $47,588.00 - $67,817.00 - $88,047.000 Scheduled Weekly Hours: 40 Work Shift: Job Description: Pay Range: $46,655.00 - $66,488.00 - $86,321.00 (min - mid - max) Job Duties: Manage day to day clinical trial operations. Submissions to IRB to be prepared according to regulations and deadlines including: applications, renewal, adverse events, write informed consent document and amendments, protocol amendments. Case Reports Forms and source documentation to be completed and maintained accurately, truthfully, and timely. Obtain informed consent under the direction of the Principle Investigator and maintain accurate informed consent documents for later review. Ensure study-required clinical elements and tests are conducted and collected according to the protocol. Train staff on various aspects of conducting clinical trials. Serve as an expert resource on conducting clinical trials and mentor to junior staff. Call responsibilities on a rotational basis with other research personnel in the department. Will be a resource for all clinical needs and available to answer study related questions or talk with patients about study participation. Design and implement department wide tools necessary to conduct clinical trials in the necessary clinical settings; inpatient units, O.R., outpatient clinic, laboratory, radiology etc. Design and implement tools for the department in regards to IP. Review Sponsor protocols and make recommendations as to the feasibility of conducting a particular trial at our center given the available resources and patient population. Also, make recommendations for necessary protocol changes prior to accepting a protocol. Negotiate ongoing and new budgets. Travel to Sponsor initiated investigator meetings with investigator to review protocols for initiation and to review clinical findings during a trial as needed. Prepare for and conduct monitor and auditor visits for each study as required by sponsor, FDA or internal auditing. Serve as an expert resource for creating and implementing corrective action plans. Additional Job Description: Minimum Requirements: A bachelor's degree and two years of relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) 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) If you like working with energetic enthusiastic individuals, you will enjoy your career with us! 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. Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.