Research Assistant 1 - Cancer Population Sciences (Holowatyj Lab)

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Organization:

Epidemiology Research Staff

Job Summary:

Under moderate supervision, this individual is responsible for coordinating the approval processes and conduct of clinical oncology research protocols/studies in the Holowatyj Laboratory & Team, such that the integrity and quality of the clinical/translational research is maintained, the study objectives are accomplished, and the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols. Manages study paperwork/procedures and study conduct from planning through closeout. Performs or implements processes to assure study-related procedures are performed as required and objectives and timelines are met. Maintains accurate and timely documentation and communication with Investigators, participants, IRB, sponsors and other research related entities. With supervision, this position will also set up and support cancer population sciences research projects/studies in the Holowatyj Laboratory and Team.

Department Summary

The Division of Epidemiology is committed to

• Conducting research to enhance and expand our understanding of the

distribution and determinants of disease

• Promoting collaboration aimed at translating research into cost-effective

strategies of disease prevention and health care delivery

• Training independent investigators in epidemiology research and disease

prevention

Our faculty share a broad interest in the research of genetics, nutrition, and other lifestyle and environmental factors.

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KEY RESPONSIBILITIES

• Conveys a basic knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in the conduct of research:

• Possesses a basic awareness of the Federal regulations and guidelines governing the protection of human subjects (e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations), before engaging in human subjects research

• With assistance, prepares and processes new IRB research proposals, amendments, approvals, use/sharing agreements, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations

• Communicates a basic knowledge and understanding of the management and implementation of clinical/translational research operations

• Exhibits the capability to understand and follow a clinical/translational study protocol, obtaining training and seeking assistance when needed, to safely and accurately perform or assess required protocol procedures. Uses coordination skills and works collaboratively with other staff and departments/institutions to complete research protocols, including performing study procedures

• Prepares and maintains documents required to be maintained and available internally and for regulatory authorities and/or the sponsor prior to, during and after the conduct of clinical studies. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures

• Procures equipment and supplies needed to fulfill project requirements

• Records/organizes data from source documentation with awareness and attention to the requirements for accuracy, completeness and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice

• Develops and maintains patient databases, investigational logs and records of procedures followed

• Familiar with the safety reporting requirements of the study protocol, FDA and other regulatory bodies. In a timely capacity, coordinates activities and gathers information from a variety of sources to achieve stated outcomes

• Performs data transfer to the sponsor or laboratory in accordance with appropriate privacy guidelines and regulations, maintaining appropriate documentation

• With direction assists with study completion, study closeout and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and performs data abstraction

• With supervision, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance

• Assists the Principal Investigator in the development of study protocols.

• Collaboratively participates in study team meetings. Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors

• Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants

• Engages in open and positive communication with study partners and coworkers

• Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance

• Supervises, mentors and trains new or junior research staff/interns

• Encourages open communication with research colleagues by providing them with contact information and being available to answer, address or refer their calls

• With direction, performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and in a timely manner reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine if a protocol amendment or other safety reporting to appropriate funding/regulatory agencies is required

• Utilizes or obtains knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations

• Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to continue education (i.e., in-services, seminars, etc.)

• Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work

• Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor

• Record, compile, interpret, and communicate data/results

• Follow University safety protocols (may include use of combustibles, radioactivity, toxic material, and/or carcinogens), and prepare/maintain laboratory safety documents required to be maintained and available internally and for laboratory safety authorities

• Assure research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice

• Transport and procure biospecimen/tissues

• Under moderate supervision, conduct and evaluate experiments and assays

• Supervise, mentor and train new or junior research staff/interns

• Conveys a basic knowledge and understanding of policies, procedures, and regulations governing human subjects research and incorporates them in the conduct of laboratory research

• Collaboratively participate in study team meetings. Maintain open and positive communications with investigators, participants, co-workers, other departments and sponsors

• Actively identify and participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursue avenues to continue education (i.e., in-services, seminars, etc.)

• Demonstrate initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seek new learning opportunities, seeing learning as part of work

BASIC QUALIFICATIONS

• Bachelor's Degree (or equivalent experience) (Required)

• Prior experience in research coordination/protocols (Preferred)

• Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills (Required)

PHYSICAL REQUIREMENTS/STRENGTHS NEEDED & PHYSICAL DEMANDS

Movement

• Occasional: Sitting: Remaining in seated position, Standing: Remaining on one's feet without moving., Walking: Moving about on foot., Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another, Push/Pull: Exerting force to move objects away from or toward., Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles, Reaching below shoulders: Extending arms in any direction below shoulders., Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands

Sensory

• Occasional: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision. Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry.

• Continuous: Communication: Expressing or exchanging written/verbal/electronic information.

Environmental Conditions

• Occasional: Chemicals and Gasses: Medications, cleaning chemicals, oxygen, other medical gases used in work area., Pathogens: Risk of exposure to bloodborne pathogens and other contagious illnesses.

• Occasional: Chemicals and Gasses: Medications, cleaning chemicals, oxygen, other medical gases used in work area., Pathogens: Risk of exposure to bloodborne pathogens and other contagious illnesses.

Our Academic Enterprise is one of the nation's longest serving and most prestigious academic medical centers. Through its historic bond with Vanderbilt University and integral role in the School of Medicine, Vanderbilt Health cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year.

World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.

Aligning with Vanderbilt Health's Strategic Directions , the Office of Research provides shared research resources, administrative expertise and professional guidance to enable the trans-disciplinary environment and highly collaborative culture that advances discovery and training for all the research faculty, trainees, students and staff.

Core Accountabilities:

Organizational Impact: Delivers job responsibilities that impact own job area/team with some guidance. Problem Solving/ Complexity of work: Uses existing procedures, research and analysis to solve standard job related problems that may require some judgement. Breadth of Knowledge: Requires subject matter knowledge within a professional area to meet job requirements. Team Interaction: Individually contributes to project/ work teams.

Core Capabilities :

Supporting Colleagues: - Develops Self and Others: Continuously improves own skills by identifying development opportunities.- Builds and Maintains Relationships: Seeks to understand colleagues priorities, working styles and develops relationships across areas. - Communicates Effectively: Openly shares information with others and communicates in a clear and courteous manner. Delivering Excellent Services: - Serves Others with Compassion: Invests time to understand the problems, needs of others and how to provide excellent service. - Solves Complex Problems: Seeks to understand issues, solves routine problems, and raises proper concerns to supervisors in a timely manner. - Offers Meaningful Advice and Support: Listens carefully to understand the issues and provides accurate information and support. Ensuring High Quality: - Performs Excellent Work: Checks work quality before delivery and asks relevant questions to meet quality standards.- Ensures Continuous Improvement: Shows eagerness to learn new knowledge, technologies, tools or systems and displays willingness to go above and beyond. - Fulfills Safety and Regulatory Requirements: Demonstrates basic knowledge of conditions that affect safety and reports unsafe conditions to the appropriate person or department. Managing Resources Effectively :- Demonstrates Accountability: Takes responsibility for completing assigned activities and thinks beyond standard approaches to provide high-quality work/service. - Stewards Organizational Resources: Displays understanding of how personal actions will impact departmental resources. - Makes Data Driven Decisions: Uses accurate information and good decision making to consistently achieve results on time and without error. Fostering Innovation: - Generates New Ideas: Willingly proposes/accepts ideas or initiatives that will impact day-to-day operations by offering suggestions to enhance them.- Applies Technology: Absorbs new technology quickly; understands when to utilize the appropriate tools and procedures to ensure proper course of action. - Adapts to Change: Embraces changes by keeping an open mind to changing plans and incorporates change instructions into own area of work.

Position Qualifications:

Responsibilities:

Certifications :

Work Experience :

Relevant Work Experience

Experience Level :

Less than 1 year

Education :

Bachelor's

Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and to the principles of equal opportunity and affirmative action. EOE/AA/Women/Minority/Vets/Disabled