UNIV - Clinical Research Assistant (General Pharmacy) - Department of Medicine: Division of Pulmonar

Job Description Summary

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Job Description

Job Duties:

25% - Works on projects and assists with subject-related activities as needed including: performing clinical assessments such as EKG, PFT, 6MWT, vitals monitoring, and other research procedures as dictated by the protocol; processing, storing, and shipping laboratory specimens within acceptable guidelines; completing subject reminder phone calls; rescheduling subject appointments as necessary; retrieving external medical records; completing initial medical history review of subjects; managing shipments of study related items to and from subjects and CRO/sponsors.

20% - Responsible for meticulous and careful pharmacy management for clinical trials, including, but not limited to: receiving study drug and/or device shipments; managing IVRS/IWRS/IXRS forms; documenting receipt, dispensation, return, destruction and quarantine of investigational product/devices when applicable in pharmacy binder; monitoring temperature control; acting as the Investigational Drug Services (IDS) liaison for the  Pulmonary & Critical Care Clinical Research Program; providing education on the pharmacy process to the research team; meeting and reviewing pharmacy documentation with the research monitors.  Will also be responsible for preparing IP accountability files for on-site monitoring visits, sponsor audits and regulatory authority audits, as well as reconciling and resolving action items following said on-site visits.

20% - Provides research administrative support to each of the research protocols and staff including, but not limited to:  assisting in any events, meetings, and trainings for the program by scheduling rooms, arranging catering, taking minutes, and making copies as needed; sorting, delivering and stocking all mail, shipments, and faxes daily; providing phone coverage as needed; tracking inventory of all supplies and ensuring appropriate level of supplies are maintained. Provides support to Research Coordinators by: serving as liaison to CRO/sponsor visitors while on-site monitoring a study; preparing binder carts for said visitors prior to arrival; ensuring monitor supplies are available and stocked on cart; working with CRO/sponsor representatives to resolve discrepancies; collecting binder cart and investigational product/devices from monitor immediately after his/her departure from the site.

20% - Responsible for entering all data into the appropriate database in a timely manner per research agreement and resolving any discrepancies that arise.

10% - Maintains, inventories and archives program equipment and resources by:  scheduling annual calibration of all equipment; setting up new equipment and logging each item as received; trouble shooting equipment as needed; addressing day-to-day issues that may arise; tracking storage of completed studies; building binders for each new clinical trial; filing documents associated with each study; providing assistance to the regulatory team as required.

5% - Perform other duties as required.

Additional Job Description

Minimum Requirements: A high school diploma and three years of relevant program experience. A bachelor's 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 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. (Continuous) 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 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 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 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. (Infrequent)

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.

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