Job Description Summary
The Research Assistant will support clinical research activities within the Pediatric Research Group. This role will have direct patient interaction and work on minimal risk studies independently. Research Assistants help with and participate in the day-to-day operations related to the collection compilation and documentation of clinical research data. This role will support other PRG coordinators with interventional drug studies under direct supervision.
Medical University of South Carolina MUSC - UnivWorker TypeEmployeeWorker Sub-TypeResearch GrantCost CenterCC001014 COM PEDS Clinical Research CCPay Rate TypeHourlyPay GradeUniversity-04Pay Range33339.00 - 47509.00 - 61680.000Scheduled Weekly Hours40Work Shift
Job Description
The Research Assistant will support clinical research activities within the Pediatric Research Group. This role will have direct patient interaction and work on minimal risk studies independently. Research Assistants help with and participate in the day-to-day operations related to the collection compilation and documentation of clinical research data. This role will support other PRG coordinators with interventional drug studies under direct supervision.
MUSC Minimum Requirements
A high school diploma and two years relevant program experience. A bachelors degree may be substituted for the required program experience.
The Research Assistant will:
Collect process ship and maintain inventory of research biological specimens Schedule study visits and assessments per protocol Maintain accurate and up-to-date paper and electronic regulatory documents Complete data entry in a timely manner including query resolution Help study recruitment efforts by completing pre-screening phone calls reviewing medical charts and speaking with subjects directly about enrolling studies during clinic visits Prepare lab kits for upcoming study visits monitor the inventory of lab kits and study specific supplies and destroy expired lab kits as needed Provide support to other PRG coordinators during study visits as needed. This includes calling subjects to confirm appointments filling documents obtaining signatures from research staff in other MUSC locations assisting with medical history and adverse event collection and documentation and reviewing outside medical records Assist with study specific worksheet and source document creation
Position Requirements
This position will be required to work on campus but may be eligible to work a hybrid work from home model after a probationary period. Position may also require weekend or after-hours work.
Job Duties
Research Operations
• Provides administrative support of recruitment strategies prepares mailings distributes flyers phone marketing etc. • Provides administrative pre-screening support to study team may maintain logs and data entry related to screening • Schedules participants for study visits • May also assist with the preparation and gathering of study supplies equipment and documents as needed • Conducts visits for minimal risk studies independently • May also perform assessments for minimal risk studies or for greater than minimal risk studies under direct supervision • Collects data directly from participant or from the electronic medical record • Collects prepares ships and or maintains inventory of biological research specimens and processes and ships labs • Conducts and or documents consent for participants in minimal risk studies • May conduct consent for studies greater than minimal risk under direct supervision • Files regulatory documents and reports • Creates a broad array of regulatory submissions initial study applications for minimal risk studies • Creates and submits simple regulatory reports personnel amendments and continuing review applications to the IRB • Prepares for study monitoring and study audit visits • May assist with addressing findings and resolving queries under supervision • Collects prepares or processes adverse events under supervision • Administratively files external SAE reports or IRB SAE reports
Data and Informatics
• Completes case report forms and enters data into EDC systems • Resolves data queries • Creates and develops simple databases • Assists with the creation of simple data collection forms surveys CRFs and or source documents
Communication
• Schedules and coordinates team meetings • Assists with preparing meeting documents
Site and Study Management
• Maintains study compliance with institutional requirements and other policies and maintains the Delegation of Authority Logs
Ethics and Participant Safety
• Understands the ethical conduct of research and safeguards needed when conducting human subjects research activities • Under supervision adheres to management plans related to conflict of interest
Other
• Administrative and other duties as assigned
Minimum Requirements
A high school diploma and three years of relevant program experience. A bachelors degree may be substituted for the required 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 walkingmobile Frequent Ability to work indoors Continuous Ability to work outdoors in all weather and temperature extremes Infrequent Ability to work in confinedcramped 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 handsarms Continuous Ability to perform repetitive motions with handswristselbows 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 lift objects up to 15 lbs from floor level to height of 36 inches unassisted Infrequent Ability to lower objects up to 15 lbs from height of 36 inches to floor level unassisted Infrequent Ability to pushpull objects up to 15 lbs unassisted Infrequent Ability to maintain 2040 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 distancerelationship between objects depth perception Frequent Good peripheral vision capabilities Continuous Ability to maintain hearing acuity with correction Continuous Ability to hear and or understand whispered conversations at a distance of 3 feet Frequent Ability to perform gross motor functions with frequent fine motor movements Frequent Ability to work in dusty areas
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 httpwww.uscis.gove-verifyemployees