The selected candidate will be responsible for partnering with research coordinators to provide accurate, complete, and timely data entry related to all research protocols and follow up patients.
Provides support and follow-up to Research Coordinators and Study Management Specialist on any and all clinical trial protocols. Works closely with community physicians and other medical professionals related to research activities.
TYPICAL PHYSICAL DEMANDS: Requires prolonged sitting, some bending, stooping and stretching to include lifting charts or boxes weighing up to 30 pounds. Requires eye-hand coordination and manual dexterity sufficient to operate standard office equipment. Requires normal range of hearing and eye sight to record, prepare and communicate appropriate reports. Requires the ability to facilitate a variety of delivery/pick-up/errand activities at off-site locations.
TYPICAL WORKING CONDITIONS: Work is performed in an office/clinic environment. Occasional evening or weekend work. Interaction with others is constant and interruptive.
EXAMPLES OF DUTIES: (This list may not include all of the duties assigned.)
1. Coordinates department and physician needs by gathering records, reports, correspondence or other information as delegated through the Research Manager.
2. Interpersonal skills to work with patients, their families, physicians, clinic, research team, administrators and representatives from sponsors.
3. Assists in the Study Coordinator and Study Management Specialist in preparation for Monitor visits, and visits by other auditors.
4. Interact with patients at study visits to collect data as delegated through the Research Manager.
5. Works with the Study Management Specialist in efforts to ensure up-to-date regulatory documents for investigators, associated research personnel, local laboratories and other relevant entities.
6. Manages the timely and accurate data submission for all patient follow-up visits.
7. Processes/ships central laboratory required blood and urine specimens. Perform protocol mandated ECGs, and vitals collection as needed
8. Work independently to obtain, abstract and code complex clinical information from multiple sources. Enters collected study data into sponsor specific systems (case report forms, adverse events, concomitant medications, etc.) within 1 week of protocol visit.
9. Partners with research coordinators to ensure accurate reporting from various internal and external research partner databases.
10. Assist Research Coordinators in insuring proper billing of research charges and protocol specific scheduling.
11. Works with Research Manager on QA and QI reporting metrics.
12. Supports the research team through participation in continuous process improvement, active participation in department meetings, and participation in training of new personnel. Utilizes department SOP’s to expedite accurate documentation and recordkeeping.
13. Assists with research-related fundraising events and publications as needed. Attends meetings as requested.
14. Assists with managing Website content to ensure timeliness and accuracy of Research related information.
15. Participates in professional development activities to keep current with health care trends and practices.
16. Handles confidential matters concerning clinic policies and practices in accordance with HIPAA regulations.
17. Performs related work as required.
Date of Listing
40 Hours Per Week
> Knowledge of clinical trial protocols.
> Knowledge of IRB documentation and submission requirements.
> Knowledge of organizational policies, procedures and systems.
> Skill and experience at interpreting medical charts and abstracting data from medical records.
> Ability to use computer systems and technology for all aspects of clinical trials including but not limited to data management, coordination of patient activities and follow up.
> Ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently.
> Ability to establish and maintain effective working relationships with employees, patients, general public and other community organizations.
> Ability to work as part of a team and independently.
> Requires strong written, verbal, and problem solving skills.
> Requires attention to detail, strong time management and organizational skills.
> Requires a Bachelor degree in science or a related field or a minimum of one year experience in a relevant role.
Employee must pass the Sansum Clinic pre-placement physical screening exam.