13 UNIV - Research Program Coordinator I - Novice - Department of BMIC Jobs in Charleston, SC
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UNIV - Research Program Coordinator I - Novice - Department of BMIC
$62k-82k (estimate)
Full Time
2 Months Ago
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MUSC Health is Hiring an UNIV - Research Program Coordinator I - Novice - Department of BMIC Near Charleston, SC
Job Description SummaryJob Summary: The Biomedical Informatics Center (BMIC) Clinical Research Coordinator will provide technical and professional research services within BMIC and assist Principal Investigators (PI) with the coordination of human subject research activities as delegated by the PI and Program Manager I. Responsibilities may include the recruitment of study participants, scheduling and performing in clinic or remote study visits, data collection, conducting research assessments, facilitating data workgroups, in addition to creating and maintaining up to date research regulatory files and IRB submissions.
EntityMedical University of South Carolina (MUSC - Univ)
Worker TypeEmployee
Worker Sub-Type Research Grant
Cost CenterCC000955 COM Biomedical Informatics Center CC
Pay Rate TypeHourly
Pay GradeUniversity-05
Pay Range$37,860 - $53,957 - $70,054
Scheduled Weekly Hours40
Work ShiftJob DescriptionJob Duties:
Additional Job DescriptionMinimum Requirements: A bachelor's degree and one year 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. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
EntityMedical University of South Carolina (MUSC - Univ)
Worker TypeEmployee
Worker Sub-Type Research Grant
Cost CenterCC000955 COM Biomedical Informatics Center CC
Pay Rate TypeHourly
Pay GradeUniversity-05
Pay Range$37,860 - $53,957 - $70,054
Scheduled Weekly Hours40
Work ShiftJob DescriptionJob Duties:
- 35% - Synthesizes and interprets recruitment reports to assess effectiveness of recruitment strategies and implements innovative solutions to maximize recruitment strategies by allocating resources appropriately. Screens participants independently and provides oversight and training to study team members who screen participants. Provides oversight and training to study team members, including clinic staff, regarding preparation of study visits, maintenance of subject level documentation and creation of study level SOPs. Independently conducts study visits and may perform complex research assessments. Extracts complex data from electronic medical records. May train others to conduct study visits and perform protocol specific testing/interviews. Creates, optimizes, and oversees systems to collect, prepare, process, ship, and maintain inventory of research specimens and trains others on these tasks. Conducts and/or documents consent for participants in a variety of studies independently. Applies knowledge of human subjects’ protection regulations in the informed consent process. Assists with management and tracking of IP at the protocol and subject level. Employs the required system for handling, dispensing, and documentation of IP for sponsored protocols. May be responsible for determining the best methods for handling & documenting IP for investigator-initiated protocols and coordination with investigational pharmacies as necessary. Ensures studies are carried out according to Code of Federal Regulations, Good Clinical Practices, and MUSC policies. Maintains accurate study registration (Clinicaltrials.gov, etc.). Independently creates regulatory submissions and annual reports to regulatory authorities and funding agencies (NIH, FDA, etc.) and completes required supplemental regulatory documents (IND/IDE, Certificate of Confidentiality, etc.) for all studies and trains other staff in these tasks. Acts as a liaison for multi-site studies, managing regulatory submissions and reporting across all participating sites and with the IRB of record. Provides direction to study teams with preparation for study monitoring and study audit visits. Implements corrective action plans, including re-training of staff as needed. Serves as an expert resource when addressing and correcting findings. Collects, prepares, or processes adverse event information independently. Completes IRB and/or sponsor reportable events independently. Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events. Reviews study participant charges, identifies discrepancies, and escalates to appropriate offices to ensure appropriate research billing compliance. - (Essential)
- 20% - Coordinates efforts and data for external monitoring boards and independently facilitates and submits the completion of documents related to Research Data Security Plans, Data Safety and Monitoring Plans, and Conflict of Interest. Employs safeguards for human subject protection and/or ensures vulnerable population regulations are adhered to and mitigated. Proactively identifies potential problems and risks to the participant, study, investigator, research team, and institution and implements conflict management plans per regulations and institutional policies. Takes part in a committee, taskforce, or ad hoc group within a department. May participate in presentations and/or publications. Trains staff on various work responsibilities and assigns responsibilities to junior staff. Provides constructive feedback to team members. Identifies, discusses, and recommends strategies to enhance diversity in clinical trials. - (Essential)
- 15% - Performs literature reviews under direction of PI or supervisor. Provides administrative assistance with grant proposals and applications. Assists with organizing study results. Prepares for and participates in team meetings. Serves as a primary liaison between Sponsor, PI, vendors, sub-contracts, and ancillary services including Investigational Drug Services Pharmacy, Lab, Imaging, NEXUS, and Hospital services, etc. - (Essential)
- 15% - Uses EDC systems to enter data independently and train others on these tasks. Detects issues related to data capture, collection or management and suggests solutions. Creates and develops complex databases using research methodology knowledge. Creates complex data collection forms (CRFs and/or source documents) according to protocol. Exports data to include simple data analysis, and/or reporting of data. - (Essential)
- 15% - Collects information related to recruitment numbers and resources for study teams to help determine site trial feasibility. Serves as an internal Quality Assurance Monitor and develops and implements protocol-specific quality assurance plans. Conducts site-initiation, interim, and close-out monitoring visits, writes monitoring reports, and develops corrective action plans related to visit findings. Determines and allocates resources at a study level. Develops study protocol-specific systems and documents including process lows, training manuals, standard operating procedures, and case report forms. Maintains study compliance with institutional requirements and other policies and maintains the Delegation of Authority Logs. - (Essential)
Additional Job DescriptionMinimum Requirements: A bachelor's degree and one year 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. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
Job Summary
JOB TYPE
Full Time
SALARY
$62k-82k (estimate)
POST DATE
07/13/2024
EXPIRATION DATE
08/07/2024
WEBSITE
muschealth.org
HEADQUARTERS
Charleston, MS
SIZE
<25
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