UNIV - Research Data Core Lead -Hollings Cancer Center

Job Description

Summary

Under general supervision of the Clinical Trials Office (CTO) and Data Core Manager within the Clinical Operations Unit, this position is responsible for study participant sample procurement, processing, handling, and banking according to clinical trial protocols.

Performs accurate and timely data entry and record keeping in sample database and maintains all records relating to clinical trial lab management.

Responds appropriately to clinical trial study team inquires in a timely manner. Knowledge of laboratory facilities, methods, equipment, materials, and laboratory safety practices, as well as human subjects research.

Responsible for compliance with study requirements as well as all MUSC, CTO, state, and federal guidelines.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type

Classified

Cost Center

CC001332 HCC CTO Administration

Pay Rate Type

Salary

Pay Grade

University-06

Pay Range

46,655.00 - 66,488.00 - 86,321.000

Scheduled Weekly Hours

Work Shift

Job Description

35% Unit Development and Strategic Planning- In collaboration with the Data Core Manager, this position will support the identification and implementation of new initiatives to streamline and increase efficiencies of data management activities.

This position will help develop strategic plans for the creation of a centralized data management core within the CTO. This may involve the creation and maintenance of new training and process guides for specimen processing and handling and implementation of corrective action plans related to data underperformance or deficiencies.

Participates in staff training and new employee orientation and education regarding data management. Works effectively and cooperatively with colleagues, assists with audits and routine monitor visits.

Will work closely with the Data Core Manager and Quality Assurance and Education unit to onboard new clinical operations staff to develop data management skills.

Will review data management performance metrics and proposed new initiatives to leadership.

30% CTO Lab Processing- Receive and prepare biospecimens for analysis by performing various processing techniques (centrifugation, aliquoting, etc.

according to protocol processing requirements. Collaborate with CTO staff to coordinate biospecimen-related activities.

Operate and maintain laboratory equipment used in biospecimen processing. Perform routine calibration, maintenance, and troubleshooting of equipment.

Assist in the review and reporting of data; document and report any atypical findings for molecular and specimen processing labs to clinical trial principal investigators, study teams, sponsors, and monitors.

Respond to requests for information and queries pertaining to processing procedures and records in a courteous and timely manner.

Communicate effectively to report any deviations or issues in processing protocols. Prepares, transports, and handles blood borne pathogens and other biologic specimens following OSHA and IATA guidelines.

Ensure collection and submission of pathology specimens are submitted to study sponsor at designated time points per protocol.

Update the Clinical Trial Management System (CTMS), OnCore, patient calendars to mark samples as completed.

20% Start-up and Amendments- Responsible for reviewing lab manuals for all CTO trials under consideration to identify any barriers that may affect trial feasibility.

Process lab manuals for all new studies in start-up by building the biospecimen processing workflow in the sample management platform, Slope.

Review amendments to lab manuals and update the sample management platform when needed. Assist in the development and implementation of policies, procedures and protocol written instructions to ensure compliance with regulatory standards.

Maintain lab supply inventory using inventory system.

15% Data Management Support- Timely and accurately submits data to established research bases including the National Cancer Institute, industry sponsors and MUSC.

Maintains subject research charts and submits data for assigned patient caseload. Patient management will include multiple disease programs and protocols.

Protocol management will include NCI Cooperative group, Investigator Initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC).

Interprets protocols, informed consents and case report forms to develop and use study related forms, data, calendars and documents according to accepted clinical trials professional standards.

Meticulous data management is required for assigned studies and patient caseload.

MUSC Minimum Training and Experience Requirements :

A bachelor's degree and two years of relevant program experience.

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.

For further information about the E-Verify program, please click here : http : / / www.uscis.gov / e-verify / employees