Research Associate : MCG-Clinical and Trans Sci

Augusta University

Augusta (GA)

On-site

USD 45,000 - 65,000

Full time

35 hours ago

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Job summary

Augusta University is seeking a Research Associate to conduct responsibilities for assigned clinical studies and assist investigators with recruitment, data entry, and regulatory documents. The role supports the Clinical Trials Office and adheres to FDA and IRB guidelines.

The position requires multi-tasking, professional communication, and the ability to work with investigators, staff, and participants across campuses. A strong grounding in clinical research is preferred.

Qualifications

Master's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area and experience in research, basic science or clinical laboratory particularly clinical trial research.

Responsibilities

RECRUITMENT OF NEW STUDY PARTICIPANTS: Recruitment of new study participants to include screening/randomization. Management of study documents, regulatory, data entry and as requested assist with unfunded and/or investigator initiated studies.

Skills

Interpersonal communication

Written communication

Verbal communication

Attention to detail

Prioritization

Organizational skills

Critical thinking

Confidentiality

Education

Master's degree in chemistry, biology, biochemistry, cell biology or related field

Bachelor's degree in chemistry, biology, biochemistry, cell biology or related field

Tools

AU OnCore

Job description

About Us

Augusta University is Georgia's innovation center for education and health care, training the next generation of innovators, leaders, and healthcare providers in classrooms and clinics on four campuses in Augusta and locations across the state. More than 12,000 students choose Augusta for educational opportunities at the center of Georgia's cybersecurity hub and experiential learning that blends arts and application, humanities, and the health sciences. Augusta is home to Georgia's only public academic health center, where groundbreaking research is creating a healthier, more prosperous Georgia, and world-class clinicians are bringing the medicine of tomorrow to patient care today. Our mission and values https://www.augusta.edu/about/mission.php make Augusta University an institution like no other. Augusta University's distinct characteristics in education and research include real-world experiences and community engagement, as well as a culture of building community, corporate and government partnerships that address health, security, economic and societal concerns locally and across the state. The University System of Georgia https://www.usg.edu/hr/orientation/welcome_to_the_board_of_regents_university_system_office is comprised of our 26 institutions of higher education and learning as well as the System Office. Our USG Statement of Core Values are Integrity, Excellence, Accountability, and Respect. These values serve as the foundation for all that we do as an organization, and each USG community member is responsible for demonstrating and upholding these standards. More details on the USG Statement of Core Values and Code of Conduct are available in USG Board Policy 8.2.18.1.2 and can be found online at https://www.usg.edu/policymanual/section8/C224/#p8.2.18_personnel_conduct. Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found online at https://www.usg.edu/policymanual/section6/C2653.

Location

Augusta University -

Our Health Sciences Campus: 1120 15th Street, Augusta, GA 30912

Our Summerville Campus: 2500 Walton Way, Augusta, GA 30904

College/Department Information

Augusta University is actively participating in ways to improve the health and lives of the people of our community, our state, and around the world. To do this, we conduct research, a great deal of which is done through clinical trials in humans (known as human subject research). There are many federal requirements that all research institutions must meet to conduct human subject research. We have an outstanding, dynamic, and growing group of researchers, administrators, and office staff ready to assist. Our defined strengths lie in the areas of: Conventional clinical trials, community and population health, social, behavioral, and educational research. Community education, well-defined research initiation process, ongoing and continued support for conduct of research, and integrated and technology advanced IT systems to support efficient research processes.

Job Summary

Conduct research responsibilities for assigned studies. Be familiar with study protocols, assist investigators with recruiting patients for studies, screen potential patients, help enroll and randomize patients into studies. Collect and enter study data, prepare and maintain regulatory documents, resolve data queries. Schedule patient visits and procedures, perform or assist with venipuncture, prepare specimens for shipment. This position will provide assistance to the overall functioning activities of the Clinical Trials Office (CTO). The CTO is an interdisciplinary research unit that provides support for physician-initiated, grant-funded and industry sponsored clinical trials. Ability to communicate effectively and professionally. Multi-task, prioritize and work smart is crucial to this position.

Responsibilities

RECRUITMENT OF NEW STUDY PARTICIPANTS: Recruitment of new study participants to include screening/randomization. Management of study documents, regulatory, data entry and as requested assist with unfunded and/or investigator initiated studies.
ASSIST WITH AUDIT PREPARATION: As requested, assist with audit preparation as well as respond to internal audits from the AU IRB Office.
DATA ENTRY: Responsible for data entry into sponsor's EDC of choice and other data upload systems as well as maintenance of AU OnCore to include updating task lists, entering billing grid information into the financial console, and entering new patients as well as occurring completed visits.
COMMUNICATION: Must communicate clearly at all times, convey information in a professional manner which will most often involve sensitive patient data or other information.
ATTEND MEETINGS AND TRAININGS: As requested attend meetings, computer trainings and workshops.
FLEXIBLE SCHEDULE: Must be willing to work flexible hours which may include early mornings, after hours, nights and weekends which may include up to two weeks on call per month.
REVIEW STUDIES TO DEVELOP STRATEGIES FOR ENROLLMENT: Review studies to develop strategies for enrollment. Schedule pre-site visits, site initiation visits, study start up visits and monitoring visits.
TEAM PLAYER: Ability to work as a team player to include responding to all correspondence in a timely manner and adjusting daily schedules to accommodate both the patient and investigator.
KEEP INVESTIGATOR INFORMED: Keep investigator informed of patient conditions, provide assistance to investigators in the management of adverse events to include changing the workflow to accommodate study amendments and principal investigator directions.
SERVE AS PATIENT ADVOCATE: Serve as patient advocates, scheduling follow-up appointments, coordinate care with other departments, perform all laboratory and other tests as required by the protocol. Responsible for collection, processing, storage, and inventory of specimens for specific studies, assessing for adverse events, maintaining investigational devices, staff development and completion of regulatory paperwork as required by the FDA, study sponsor, and institutional policies and procedures for all assigned studies.
MAINTAIN DOCUMENTATION: Maintain all FDA, sponsor, and institutional review board documentation. Obtain and maintain complete source documentation. Accurate and timely completion of all case report forms and other data entry as required by the sponsor and local institutional data management programs.
OTHER: Perform all other duties as assigned.

Required Qualifications

Master's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and experience in research, basic science or clinical laboratory particularly clinical trial research.
Bachelor's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and a minimum of three years' research and/or clinical experience.

Preferred Qualifications

Some previous experience with social/behavioral science (public health) research is desirable. Previous supervisory experience.

Knowledge, Skills, & Abilities

KNOWLEDGE

Proficient in Microsoft Office and other computer software/databases.

Skills

Excellent interpersonal, written, and verbal communication skills.
Detail-oriented with strong prioritization, organizational skills and critical thinking skills.

Abilities