28 Clinical Development Director jobs in Durham

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Join to apply for the Medical Director - Rheumatologist (Clinical Trials) role at Piper Companies

Piper Companies is currently looking for an experienced Medical Director of Rheumatology to join a global CRO and their sponsor partner dedicated to improving health by helping deliver life-changing medicines.

The Medical Director of Rheumatology will provide medical support and advice from a 100% remote setting.

Responsibilities of the Medical Director of Rheumatology:

• Deliver advanced medical leadership and monitoring for real time clinical studies
• Aide in clinical site selection, review and approval of study protocols, CSRs, ICFs, and CRFs
• Serve as the medical point of contact and communicate with stakeholders and healthcare authorities
• Ensure timely identification and resolution of medical issues while maintaining the safety of study subjects
  
  

• 4+ years of proven clinical experience managing Rheumatology patients
• 3+ year clinical trials & drug development experience required
• MD or equivalent degree and US Board Certification in Rheumatology required
• In-depth understanding of regulatory guidelines required
  
  

• Salary Range: $300,000 - $50,000 based on professional experience
• Comprehensive benefits including Medical, Dental, Vision, 401k, PTO, Paid Holidays, sick leave if required by law
  
  

• Seniority level Not Applicable

• Employment type Full-time

• Job function Health Care Provider
• Industries Business Consulting and Services

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Piper Companies is currently looking for an experienced Medical Director of Rheumatology to join a global CRO and their sponsor partner dedicated to improving health by helping deliver life-changing medicines.

The Medical Director of Rheumatology will provide medical support and advice from a 100% remote setting.

Responsibilities of the Medical Director of Rheumatology:
• Deliver advanced medical leadership and monitoring for real time clinical studies
• Aide in clinical site selection, review and approval of study protocols, CSRs, ICFs, and CRFs
• Serve as the medical point of contact and communicate with stakeholders and healthcare authorities
• Ensure timely identification and resolution of medical issues while maintaining the safety of study subjects

Qualifications of the Medical Director of Rheumatology:
• 4+ years of proven clinical experience managing Rheumatology patients
• 3+ year clinical trials & drug development experience required
• MD or equivalent degree and US Board Certification in Rheumatology required
• In-depth understanding of regulatory guidelines required

Compensation for the Medical Director of Rheumatology:
• Salary Range: $300,000 - $350,000 based on professional experience
• Comprehensive benefits including Medical, Dental, Vision, 401k, PTO, Paid Holidays, sick leave if required by law

This job opens for applications on 8/4/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords:

Medical director, rheumatology, internal medicine, inflammation, medical monitoring, clinical trial, physician, leadership, advice, support, resolution, risk mitigation, deviation, protocol, clinical study, clinical, CRO, escalation, regulatory, communication, presentation, remote, east coast

#LI-PB2 #LI-REMOTE

Position Summary

The purpose of this position is to lead the clinical development activities in support of domestic and international clinical development initiatives.

The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities.

The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA and/or Global filings.

Key Job Responsibilities

• Conceives, implements, and analyzes drug development programs, including:

• Understanding pharmacology of drugs and unmet medical needs.

• Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy.

• Working with experts and consultants in the field to refine a clinical development strategy.

• Designing clinical trials for the purpose of meeting specific objectives.

• Anticipating and addressing future commercial and clinical development needs, based on the clinicalcharacter of the compound.

• Implements clinical development programs, including:

• Co-authoring global clinical development plans with all practical elements.

• Leading and motivating the clinical development team to operationalize the clinical develop strategy,i.e., clinical trials management.

• Partnering with internal and external clinical experts and consultants to optimize the scientific integrity of the methodology and ensure the safety of clinical subjects.

• Leading clinical trial projects to ensure all aspects of the clinical trial project plan (e.g., enrollment, database lock) are achieved on time and with the highest quality.

• Developing and leading formal presentations of results to the medical community, in written, verbal, andvisual formats.

• Analyzes and interprets the results of clinical programs in collaboration with clinical, biometric and clinical pharmacology experts.

• Partners with biostatistics, medical writers, and external consultants to understand and present the results ofclinical development programs.

• Partners with internal decision makers to evaluate critical decision points.

• Acts as a signatory for the medical monitoring team.

• Contributes to corporate initiatives by participating in continuous process improvement to meet companyobjectives as well as evaluates in-licensing opportunities and/or additional life cycle management opportunities.

• Participates in NDA development, submission and defense.

• Lectures at national and international meetings, scientific advisory board meetings, and data safety monitoring boards.

• Mentors junior team members.

Knowledge, Skills, Competencies, Education, and Experience

Required:

• A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. Board certification in Psychiatry and Neurology is highly desired. Minimum of five years of clinical research experience (post Academia).

• Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).

• An advanced understanding of clinical medicine and science.

• Advanced understanding of drug development principles and clinical trial implementation and management.

• Complete understanding of the global regulatory requirements.

• Working knowledge of marketing and commercialization.

• Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.

• Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,

• Demonstrated experience in leading a successful regulatory filing.

• Ability to work across different therapeutic areas and different stages of clinical development.

• Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).

• Strong communication and presentation skills.

• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).

• Knows how/when to apply organizational policy or procedures to a variety of situations.

Physical Demands and Work Environment

Travel (approximately 30 % )

See document Physical Demands and Work Environment for further requirements.

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; .

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ( ) .

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: . If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Piper Companies is seeking a detail-oriented and proactive Clinical Research Coordinator (CRC) to join our growing clinical research team. The ideal candidate will have hands-on phlebotomy experience and a strong background working within a clinical site network environment. This role is essential in supporting the execution of clinical trials across multiple therapeutic areas.Responsibilities for the Clinical Research Coordinator: Coordinate and manage day-to-day clinical trial activities in compliance with GCP, IRB, and protocol requirements Perform phlebotomy and process biological specimens per protocol Schedule and conduct study visits, including informed consent, data collection, and subject follow-up Maintain accurate and timely documentation in source documents and electronic data capture (EDC) systems Collaborate with sponsors, CROs, and site network teams to ensure protocol adherence and data integrity Assist with regulatory submissions, monitoring visits, and audit preparation Support subject recruitment, screening, and retention strategies Qualifications for the Clinical Research Coordinator: Bachelor's degree in a health-related field or equivalent experience 2-4 years of experience as a CRC or similar role in a clinical site network Certified or trained in phlebotomy with proven venipuncture skills Strong knowledge of ICH-GCP, FDA regulations, and clinical trial workflows Proficient in EDC systems, CTMS, and Microsoft Office Suite Excellent communication, organizational, and multitasking skills Compensation for the Clinical Research Coordinator:Salary Range: $55,000-$70,000 Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays

Coordinate and participate in a variety of duties involved in the collection, interpretation and documentation of data in support of research and/or information gathering activities in regards to mandated government reporting to CIBMTR for patients t Clinical Research, Specialist, Clinical, Research, Research Coordinator, Financial Coordinator, Healthcare

At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.About Duke University HospitalPursue your passion for caring with Duke University Hospital in Durham, North Carolina, which is consistently ranked among the best in the United States. The largest of Duke Health's four hospitals with 1062 patient beds, it features comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more.Clinical Research Specialist - D2 General Description of the Job ClassCoordinate and participate in a variety of duties involved in the collection, interpretation and documentation of data in support of research and/or information gathering activities in regards to mandated government reporting to CIBMTR for patients transplanted at Duke University Medical Center.Specific Duties and Responsibilities of this Job/LevelPrimary responsibilities include:Collect and submit reliable data into ABMT and CIBMTR database (>1.5% error rate)Responsible for accurate and timely data transmissionAttend ASBMT/CIBMTR Conferences as appropriateUtilize software applications for data collection and analysisPrepare for and participate in CIBMTR/FACT auditsLiaison between CIBMTR and ABMT ProgramSupport organization's efforts to maintain compliance with regulations and accreditation standards. Coordinate and participate in a variety of duties involved in collecting, interpreting, documenting and summarizing descriptive, analytical and evaluative data in support of research and/or information gathering activities to ensure timely completion of all government mandated CIBMTR as specified by the C.Y. Bill Young Legislative. Establish procedures for the procurement of data through observation, interviewing, analyzing records and other sources to ensure Duke ABMT meets the CPI goals for each quarter of the year. Coordinate the preparation of reports and analyses setting forth progress, adverse trends and appropriate recommendations or conclusions. Recommend new methods for collection and documentation of data; write and revise procedural manuals for Division of Hematologic Malignancy and Cellular Therapy as required. Assist in training of new personnel. Assist Clinical Research Coordinator and Computer Programmer develop efficient means to transfer recorded clinical research documentation to CIBMTR via FormsNet3.Preparation of clinical research information to support audit reviews conducted by internal and external sources of Duke.Process patients' consents and scan all patient related documents into Docuware document management system.Gather and prepare insurance packets to assist financial coordinators in obtaining approvals for patients coming to transplant.Gather and prepare workup packets for clinical review and sign-off prior to patient's beginning the transplant process as a "safety" precaution.ABMT database capture necessary for clinical research, financial and CIBMTR reporting (must be accurate, efficient and timely) to ensure internal and external needs of the institution are met.Ability to track assigned patients' status (i.e. work-up, unit, clinic, mobilization, pheresis, follow-up), check unit and daily lists.Prepare reports from database to include monthly reports and other reports requested.Other duties include:Identify opportunities for improved performance.Analyze data to identify adverse trends and /or undesirable performance.Utilize performance improvement techniques and methodologies.Assists with implementation strategies for enhancing performance.Evaluate effectiveness of improvement strategy through sustained monitoring of performance.Serve as a resource on performance improvement and compliance as it relates to organizational role.Produce reports of performance improvement and compliance.Develop, maintains and enhances knowledge through orientation, self-evaluation and professional development.Perform other related duties incidental to the work described herein.Minimum QualificationsEducationWork requires knowledge of basic mathematical, data collection and research principles normally acquired through an associate's degree.ExperienceWork requires one year of experience in research or a clerical setting to become familiar with the basic techniques and methods used to collect, compile, verify and store information. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCEDuke 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.

Coordinate and participate in a variety of duties involved in the collection, interpretation and documentation of data in support of research and/or information gathering activities in regards to mandated government reporting to CIBMTR for patients transplanted at Duke University Medical Center.

Specific duties and responsibilities of this job/level include:

• Collect and submit reliable data into ABMT and CIBMTR database (>1.5% error rate)
• Responsible for accurate and timely data transmission
• Attend ASBMT/CIBMTR Conferences as appropriate
• Utilize software applications for data collection and analysis
• Prepare for and participate in CIBMTR/FACT audits
• Liaison between CIBMTR and ABMT Program
• Support organization's efforts to maintain compliance with regulations and accreditation standards

Coordinate and participate in a variety of duties involved in collecting, interpreting, documenting and summarizing descriptive, analytical and evaluative data in support of research and/or information gathering activities to ensure timely completion of all government mandated CIBMTR as specified by the C.Y. Bill Young Legislative.

• Establish procedures for the procurement of data through observation, interviewing, analyzing records and other sources to ensure Duke ABMT meets the CPI goals for each quarter of the year.
• Coordinate the preparation of reports and analyses setting forth progress, adverse trends and appropriate recommendations or conclusions.
• Recommend new methods for collection and documentation of data; write and revise procedural manuals for Division of Hematologic Malignancy and Cellular Therapy as required.
• Assist in training of new personnel.
• Assist Clinical Research Coordinator and Computer Programmer develop efficient means to transfer recorded clinical research documentation to CIBMTR via FormsNet3.
• Preparation of clinical research information to support audit reviews conducted by internal and external sources of Duke.
• Process patients' consents and scan all patient related documents into Docuware document management system.
• Gather and prepare insurance packets to assist financial coordinators in obtaining approvals for patients coming to transplant.
• Gather and prepare workup packets for clinical review and sign-off prior to patient's beginning the transplant process as a "safety" precaution.
• ABMT database capture necessary for clinical research, financial and CIBMTR reporting (must be accurate, efficient and timely) to ensure internal and external needs of the institution are met.
• Ability to track assigned patients' status (i.e. work-up, unit, clinic, mobilization, pheresis, follow-up), check unit and daily lists.
• Prepare reports from database to include monthly reports and other reports requested.

Other duties include:

• Identify opportunities for improved performance.
• Analyze data to identify adverse trends and/or undesirable performance.
• Utilize performance improvement techniques and methodologies.
• Assists with implementation strategies for enhancing performance.
• Evaluate effectiveness of improvement strategy through sustained monitoring of performance.
• Serve as a resource on performance improvement and compliance as it relates to organizational role.
• Produce reports of performance improvement and compliance.
• Develop, maintains and enhances knowledge through orientation, self-evaluation and professional development.

Perform other related duties incidental to the work described herein.

Minimum qualifications:

Education: Work requires knowledge of basic mathematical, data collection and research principles normally acquired through an associate's degree.

Experience: Work requires one year of experience in research or a clerical setting to become familiar with the basic techniques and methods used to collect, compile, verify and store information. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.

Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.

Due to our continued growth, we are hiring for a Clinical Research Coordinator at Wake Research, an M3 company. This position is on-site and located in Raleigh, NC.

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

Essential Duties and Responsibilities:

• Assisting trial Investigator in screening and review of potential study participants eligibility
• Maintaining case report forms, charts and documentation
• Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants
• Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements
• Collecting and entering data as necessary
• Assist management with potential new hire selection and shadowing process
• Assist with study start-up, maintenance, and close-out of studies as needed for those on the team
• Ability to be flexible with study assignments

• Clinical Research Coordinator with 1-2 years of experience
• Phlebotomy experience is highly preferred
• Previous experience as a medical assistant, LPN, or RN
• Excellent verbal & written communication skills
• Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking
• Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines
• Extensive clinical trial knowledge through education and/or experience
• Successful completion of GCP Certification and Advanced CRC preferred
• Detail-oriented
• Familiarity with the Code of Federal Regulations as they pertain to human subject protection
• Strong interpersonal skills

A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:

• 401(k), 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

*M3 reserves the right to change this job description to meet the business needs of the organization

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.Operations:Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. 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. Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring and audit visits. Under supervision, may document some participant-level information for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Under supervision, collects information from sources including the EHR to assist study team in determining eligibility. Follows SOPs. Under supervision, employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with maintenance of study level documentation. Prepares documents, equipment, supplies, etc. in compliance with the protocol. Assists with the conduct and documentation of non-complex visits and scripted testing or interviews. Participates in study team meetings. Ethics:Under supervision may collect information about AEs, identified in the protocol or investigator brochure. Conducts and documents consent for participants in non-complex studies. These are typically repositories, survey studies, simple observational studies and non-patient studies that do not involve investigational products or devices. Cannot consent for any studies that involve investigational products or devices or require clinical research orders in Maestro Care (i.e., electronic health record). Assists with the development of consent plans and documents for participants. Under supervision, for non-complex studies (e.g., survey studies and registries), develops and submits documentation and information for IRB review. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others. Data:Enters basic data for research studies. Scores tests and measures that do not require interpretation, according to the protocol. Under supervision, corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Science:Assists with or contributes to the development of funding proposals. Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs. Study and Site Management:As directed, attends or schedules site visits. Records participant accrual information and consent documentation for non-complex studies in clinical research management system. Records basic protocol information in clinical research management system. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations. For studies with simple supplies or equipment, assists with ensuring that there are ample supplies and that equipment is in good working order. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor). 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. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates with other study personnel as required for study implementation and routine problem resolution. Type of Research:This position will support several projects within the Department of Head and Neck and will go to clinic to screen and consent for minimal risk projects and collect data Education/TrainingWork requires an associate's degree.ExperienceOne year of relevant experience. A Bachelor's degree may substitute for required experience.SkillsCan easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).Minimum QualificationsEducationWork requires an Associate's degree .ExperienceOne year of relevant experience. A Bachelor's degree may substitute for required experience.Anticipated Pay Range:Duke University provides an annual base salary range for this position as USD $20.76 to USD $31.44. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reason able accommodation will be provided by each hiring department.Duke is an 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 (including pregnancy and pregnancy related conditions), sexual orientation or military status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends onthe 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 essential job 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.