Clinical Research Coordinator - Sahlem lab- For Hire Only!

Clinical Research Coordinator - Sahlem lab- For Hire Only!

Work Arrangement : Requisition Number : 247619 Regular or Temporary : Regular Location :

Durham, NC, US, 27710

Personnel Area : MEDICAL CENTER Date : Jul 8, 2024

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe.

Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center.

The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

The Duke Psychiatric Advanced Clinical-Translational Idea Lab (PACTiLab) utilizes a multidisciplinary collaborative team to focus on the translational development of new treatments for psychiatric illnesses (with a special emphasis on addictive and mood disorders).

Our mission is to take mechanistic ideas into the clinical-research setting in the hopes of traversing the translational bridge (performing human laboratory trials, translational treatment trials from phase-1 to phase-3, and research aimed at more directly improving clinical care).

Our group embraces the tripartite academic medicine mission. Lab-members are subsequently encouraged to advance science through research, teach what they know, and improve clinical care through treatment trials.

The lab has expertise in the use of neuromodulation techniques including repetitive Transcranial Magnetic Stimulation (rTMS) and electroconvulsive therapy (ECT), but is agnostic regarding treatment modality, focused rather on any intervention that has the potential to improve how we treat psychiatric disorders.

We are excited to invite three new junior-colleagues to join a soon to be started project that is designed to improve our understanding of the neural-circuitry underling the addictive process in opioid use disorder.

The project is investigating a candidate biomarker that we hypothesize might help us understand why a given patient responds well to buprenorphine (the most commonly used medication to treat opioid use disorder), while others might not.

We are additionally investigating the efficacy of delivering a course of accelerated rTMS to a personalized brain target developed using functional magnetic resonance imaging.

If you are interested in exploring the underlying pathophysiology of addiction and testing both a candidate biomarker and rTMS to see if they can improve clinical outcomes, this might be the team to join!

There will be opportunities to learn :

• Clinical trial design and conduct.
• Administering and processing functional Magnetic Resonance Imaging.
• Administration of repetitive Transcranial Magnetic Stimulation (rTMS).
• Clinical-participant screening and assessment.
• Presentation preparation and manuscript writing.
• General scientific processes including behavioral data analysis.
• Literature searches and summary.
• Other research and clinical skills.
• Of note, there will be protected time for mutually agreed upon career development projects and learning opportunities as above.

Operations :

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation.

Addresses FDA review and / or potential hold issues in collaboration with the Principal Investigator (PI). May train or oversee others.

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.

May train others in these policies and processes. Is responsible for all aspects of managing and documenting Investigational Product (IP);

including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary.

Follows protocol schema for randomization and blinding / unblinding. May train others. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.

Addresses and corrects findings. May train others. Maintains participant level documentation for all studies, including those that are complex in nature (e.

g., procedural and interventional studies) and / or require access to the Duke EHR. May train or oversee others. Employ strategies to maintain retention rates.

Evaluate processes to identify problems with retention. May train or oversee others. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems.

Escalates issues. May train or oversee others. Screens participants for complex studies (e.g., procedural and interventional studies).

May train or oversee others. Develops or helps develop SOPs. May train or oversee others. Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures.

May train or oversee others. Maintains study level documentation for all studies, including those that are complex in nature (e.

g., procedural and interventional studies). May train or oversee others. Conducts activities for study visits in compliance with the protocol.

May train staff. Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders.

Ethics :

Identifies all AEs, and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study.

May train or oversee others. Conducts and documents consent for participants for all types of studies, including those that are complex in nature and / or require any orders in Maestro Care.

May train or oversee others. Develops consent plans and documents for participants in a variety of studies. May train or oversee others.

Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately.

May train or oversee others. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.

May train or oversee others.

Data :

Enters and collects data. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data.

Assists with quality control and data cleaning as directed. Independently responds to queries created by a CRO or the data manager.

Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate.

May develop tools for, and train others in, data quality assurance procedures. Recognizes and reports security of physical and electronic data vulnerabilities.

May develop or review data lifecycle and management plans for multiple study protocols. Follows predetermined SOPs to assist in documenting and maintaining documentation to facilitated data sharing.

Innovatively uses technology to enhance a research process. May train others.

Science :

Assists with or contributes to the development of funding proposals. Independently conducts literature searches and reviews.

Demonstrates and applies a basic understanding of open science practices and the FAIR data principals. Using scientific proposals from the PI, develops elements of research protocols.

Demonstrates a basic understanding of the elements of research study designs. Contributes to the development of scientific publications or presentations.

Serves as an author on poster presentations or publications.

Study and Site Management :

Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and / or CROs.

Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking / marking financial milestones, and all aspects of study visits.

Uses required EMR functionalities to manage participants and study visits. May train others. Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information.

May train others. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible.

May make recommendations. For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.

May forecast effort needs. May train or oversee others. Ensure that studies are conducted in compliance with institutional requirements and other policies.

Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows).

May train or oversee others. Prepares studies for closeout and document storage. May train or oversee others.

Leadership :

Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills.

May also train others in the skills learned. Keeps current with research updates by attending key external departmental meetings (i.

e. Research Wednesday, RPN, additional training, etc.). Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.

Demonstrates resilience and is adaptive to change. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Description of Portfolio Responsibilities : (Effort .%) : 100% effort, 2-year minimum commitment.

The successful applicants will be responsible for working with the rest of the study team to accomplish the following activities :

30% Recruiting participants from the community (placing advertisements, interacting with community treatment facilities etc.

describing the study and performing phone and video screening procedures,

30% performing study assessments, coordinating study-visits,

40% administering tasks during MRI scans and delivering repetitive transcranial magnetic stimulation

Description of Clinical Responsibilities :

• Assisting with participant recruitment.
• Performing phone, video, and in person study-participant screenings and describing study details.
• Administering study assessments.
• Administering tasks during Magnetic Resonance Imaging (MRI) scans.
• Administering repetitive Transcranial Magnetic Stimulation (rTMS).

Type of Research :

We will be conducting clinical-translational research in both addictive and mood disorders populations. These positions will focus on clinical-translational research in addictions.

Special skills :

• Strong interpersonal skills are needed for this clinical-participant (patient) facing position.
• This is primarily an in-person job and may require some car-travel within the community to recruit participants from treatment facilities.
• All other study skills can be learned on the job.

Minimum Qualifications

Education

Completion of an Associate's degree

Experience

Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.

Duke is an Affirmative Action / Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes.

To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard.

All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions : Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and / or mental abilities.

Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Nearest Major Market : Durham

Nearest Secondary Market : Raleigh