Senior Clinical Research Coordinator >>>

Tulane University; New Orleans (LA); On-site; USD 60,000 - 85,000; Full time

Job summary

Tulane University seeks a Senior Clinical Research Coordinator to oversee clinical trials, ensuring regulatory compliance and patient safety. This role requires strong leadership, excellent communication skills, and extensive experience in clinical operations. The coordinator will train staff, manage data, and liaise with various stakeholders.

Qualifications

• Proven ability to oversee clinical trials and their processes.
• Experience in supervising and training research staff.
• Willingness to travel for site visits.

Responsibilities

• Coordinate day-to-day operations of clinical trials.
• Ensure compliance with protocols and regulations.
• Supervise the activities of research staff.

Skills

Leadership

Communication

Problem Solving

Attention to Detail

Analytical Skills

Education

Bachelor’s Degree

Master’s Degree in a related field

RN with current state licensure

Tools

Database Management Software

Microsoft Excel

Microsoft PowerPoint

Microsoft Word

Job description

Medicine - Tulane Research Innovation for Arrhythmia Discoveries (TRIAD)

Location: New Orleans, LA

Summary

The primary responsibility of the Senior Clinical Research Coordinator is to coordinate and oversee a clinical trial, including the day-to-day operations, training and supervising research staff, recruiting patients, communicating with study clinic staff, and monitoring patient safety. The Senior Clinical Research Coordinator is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocol, the Senior Clinical Research Coordinator acts as a liaison between the patient, staff, investigator, collaborators, Institutional Review Board and sponsor. The Senior Clinical Research Coordinator performs and supervises patient recruitment, enrollment, and follow-up, data collection, entry, and quality control activities, ensuring protocol compliance and close patient monitoring, and works independently in designing, coordinating, and implementing all assigned research projects. The Senior Clinical Research Coordinator is responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files. The Senior Clinical Research Coordinator trains other staff in conducting, and may also perform as needed, simple procedures (vital signs, etc.) as called for by the study protocol(s).The Senior Clinical Research Coordinator serves as a key management and administrative role for the research project by supervising Clinical Research staff to ensure compliance with protocol, federal, and institutional requirements, and by frequently travelling to clinics to conduct trainings and site visits.

Required Knowledge, Skills, and Abilities

• Proven ability to oversee day-to-day operations of clinical trials including their respective regulatory and administrative processes including informed consent, eligibility review, protocol implementation, IRB approval, DSMP, and event reporting • Experience supervising and training research staff, including organizing, prioritizing, and scheduling work assignments in a medical setting. • Willingness to travel to visit trial clinic sites • Flexibility to work evenings and weekends, as needed, and to be available to respond promptly to all communications from study participants, trial clinical research coordinators, and clinic staff on for emergency situations or answer questions • In-depth knowledge of federal regulations pertaining to Good Clinical Practice and conducting clinical trials set forth in the Code of Federal Regulations • In-depth knowledge of IRB submission process and requirements as well as regulatory documentation • Must be able to interact well with patients and the general public • Excellent organization, analytical, interpersonal, and communication skills • Ability to maintain confidentiality in all work performed • Ability to perform, manage, and balance multiple projects and tasks simultaneously, work under time constraints, and meet deadlines • Proficient in various software programs (including database management [e.g. Access], presentation packages [e.g. PowerPoint], spreadsheets [e.g. Excel], and advanced word processing [e.g. Word]). • Ability to acquire and maintain all required CITI training certificates • Ability to acquire and maintain credentialing at all required institutions, including Tulane Medical Center and all Federally-Qualified Health Centers included in the trial • Skilled in coordinating and organizing meetings and/or special events and willingness to assume additional duties when necessary • Highly organized and detail oriented in order to ensure all study procedures are completed as described in the study protocol, ensure participants are contacted at the correct date and time for the conduct of study assessments
REQUIRED BACKGROUND CHECK, PHYSICAL, AND DRUG SCREENING FOR INCUMBENTS WHO HAVE CONTACT OR EXPOSURE TO ANIMALS OR ANIMAL TISSUES: Selected candidates must complete and pass a background check and an occupational health screening as a condition of employment. For identified jobs, a drug screening will also be required. The background investigation, required occupational health screening, and any required drug screening will be conducted after a conditional employment offer has been extended.

Required Education and/or Experience • Bachelor’s Degree

OR
• RN with current state licensure at the time of hire and five (5) years of related work experience OR • Master’s Degree in a related field and two (2) years of related work experience

Preferred Qualifications • Certification as a Certified Clinical Research Coordinator (CCRC through the Association of Clinical Research Professionals or ACRP) OR Certified Clinical Research Professional (CCRP through the Society of Clinical Research Associates or SoCRA) is strongly desired.

Description for Job: IRC32833 Senior Clinical Research Coordinator
Medicine - Tulane Research Innovation for Arrhythmia Discoveries (TRIAD)
Location: New Orleans, LA
Summary The primary responsibility of the Senior Clinical Research Coordinator is to coordinate and oversee a clinical trial, including the day-to-day operations, training and supervising research staff, recruiting patients, communicating with study clinic staff, and monitoring patient safety. The Senior Clinical Research Coordinator is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocol, the Senior Clinical Research Coordinator acts as a liaison between the patient, staff, investigator, collaborators, Institutional Review Board and sponsor. The Senior Clinical Research Coordinator performs and supervises patient recruitment, enrollment, and follow-up, data collection, entry, and quality control activities, ensuring protocol compliance and close patient monitoring, and works independently in designing, coordinating, and implementing all assigned research projects. The Senior Clinical Research Coordinator is responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files. The Senior Clinical Research Coordinator trains other staff in conducting, and may also perform as needed, simple procedures (vital signs, etc.) as called for by the study protocol(s).The Senior Clinical Research Coordinator serves as a key management and administrative role for the research project by supervising Clinical Research staff to ensure compliance with protocol, federal, and institutional requirements, and by frequently travelling to clinics to conduct trainings and site visits.
Required Knowledge, Skills, and Abilities • Proven ability to oversee day-to-day operations of clinical trials including their respective regulatory and administrative processes including informed consent, eligibility review, protocol implementation, IRB approval, DSMP, and event reporting • Experience supervising and training research staff, including organizing, prioritizing, and scheduling work assignments in a medical setting. • Willingness to travel to visit trial clinic sites • Flexibility to work evenings and weekends, as needed, and to be available to respond promptly to all communications from study participants, trial clinical research coordinators, and clinic staff on for emergency situations or answer questions • In-depth knowledge of federal regulations pertaining to Good Clinical Practice and conducting clinical trials set forth in the Code of Federal Regulations • In-depth knowledge of IRB submission process and requirements as well as regulatory documentation • Must be able to interact well with patients and the general public • Excellent organization, analytical, interpersonal, and communication skills • Ability to maintain confidentiality in all work performed • Ability to perform, manage, and balance multiple projects and tasks simultaneously, work under time constraints, and meet deadlines • Proficient in various software programs (including database management [e.g. Access], presentation packages [e.g. PowerPoint], spreadsheets [e.g. Excel], and advanced word processing [e.g. Word]). • Ability to acquire and maintain all required CITI training certificates • Ability to acquire and maintain credentialing at all required institutions, including Tulane Medical Center and all Federally-Qualified Health Centers included in the trial • Skilled in coordinating and organizing meetings and/or special events and willingness to assume additional duties when necessary • Highly organized and detail oriented in order to ensure all study procedures are completed as described in the study protocol, ensure participants are contacted at the correct date and time for the conduct of study assessments
REQUIRED BACKGROUND CHECK, PHYSICAL, AND DRUG SCREENING FOR INCUMBENTS WHO HAVE CONTACT OR EXPOSURE TO ANIMALS OR ANIMAL TISSUES: Selected candidates must complete and pass a background check and an occupational health screening as a condition of employment. For identified jobs, a drug screening will also be required. The background investigation, required occupational health screening, and any required drug screening will be conducted after a conditional employment offer has been extended. Required Education and/or Experience • Bachelor’s Degree OR
• RN with current state licensure at the time of hire and five (5) years of related work experience OR • Master’s Degree in a related field and two (2) years of related work experience Preferred Qualifications • Certification as a Certified Clinical Research Coordinator (CCRC through the Association of Clinical Research Professionals or ACRP) OR Certified Clinical Research Professional (CCRP through the Society of Clinical Research Associates or SoCRA) is strongly desired. • Supervisory experience is strongly desired Compensation Information This position is classified as "exempt, salaried" and is assigned to pay grade 26. Tulane offers a variety of options to enhance your health and well-being so thatyou may enjoy more out of life now and in the future. Learn more about Life at Tulane as well as our Benefits and Pay . See ourCandidate Resources to learn more about our hiring process and what to expect.
How to Apply This position will close on the date it is filled Please Note: Depending on your role and the department in which you work, you may be expected to adhere to COVID-19 requirements, such as vaccinations and booster shots. Click "Apply Now" to apply for this job. Tulane University is an equal opportunity educator and employer committed to providing an education and employment environment free of unlawful discrimination, harassment, and retaliation. Legally protected demographic classifications (such as a person’s race, color, religion, age, sex, national origin, shared ancestry, disability, genetics, veteran status, or any other characteristic protected by federal, state, or local laws) are not relied upon as an eligibility, selection or participation criteria for Tulane’s employment or educational programs or activities. Tulane University is responsible for providing reasonable accommodations to individuals with disabilities throughout the applicant screening process. If you need assistance in completing an application or during any phase of the interview process, please contact the Office of Human Resources by phone at 504-865-4748 or by email at [e-mail] . Apply now >>> >>> Back to Search Page <<<