- Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
- Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
- Sponsor-provided and IRB-approved Protocol Training
- All relevant Protocol Amendments Training
- Any study-specific Manuals Training, as applicable
- Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
- Conducting and overseeing study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
- Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
- Completing and overseeing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
- Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
- Demonstrated understanding, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols.
- Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives for assigned protocols.
- Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)
- Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).
- Ability to train and mentor site staff, as needed
- Supervise visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)
- Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
- Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).
- Maintaining a working knowledge of Study Participants' Scheduling, Visit Tracking, Stipends and Transportation by liaising with the Administrative team.
- Maintaining a working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)
- Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.
- Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
- Being prepared for and available at all required company meetings.
- Submitting required administrative paperwork per company timelines.
- Occasionally attending out-of-town Investigator Meetings
- Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
- Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
- Facilitate effective communication between patients, healthcare providers, and research staff
- Any other matters as assigned by management
- High School Diploma or equivalent required
- Bachelor's degree preferred
- Foreign Medical Graduates preferred
- Minimum of 5 years experience in Clinical Research
- Supervisory experience preferred
- Wide therapeutic range of clinical trials experience preferred
- Regulatory research experience is a plus
- ACRP or equivalent certification is preferred
- Goals-driven while continuously maintaining quality.
- Must be detailed-oriented, proactive, and able to take initiative.
- Must have strong written and communication skills.
- Must have excellent customer service skills.
- Proficient communication and comprehension skills both verbal and written in the English language are required.
- Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.
-
Warehouse Coordinator Iii
3 days ago
Yusen Logistics Elk Grove Village, United StatesOverview: · This is a safety sensitive position. · **Position Summary** · As a Warehouse Coordinator you must be very organized with strong attention to detail, highly customer service oriented with the ability to follow up on daily work to make sure all are completed on time and ...
-
Clinical Research Coordinator III
2 weeks ago
DM Clinical Research Oak Park, United StatesJob Description · Job Description · Clinical Research Coordinator III · A · CRC III · will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quali ...
-
Warehouse Coordinator III
1 week ago
Yusen Logistics Elk Grove Village, United StatesOverview: · This is a safety sensitive position. · Position Summary · As a Warehouse Coordinator you must be very organized with strong attention to detail, highly customer service oriented with the ability to follow up on daily work to make sure all are completed on time and ...
-
Warehouse Coordinator III
3 days ago
Yusen Logistics Elk Grove Village, United StatesOverview · This is a safety sensitive position. · Position Summary · As a Warehouse Coordinator you must be very organized with strong attention to detail, highly customer service oriented with the ability to follow up on daily work to make sure all are completed on time and acc ...
-
Physician Liaison
6 days ago
United Vein & Vascular Centers River Forest, United StatesOverview: · United Vein & Vascular Centers is a rapidly growing national healthcare organization specializing in state-of-the-art, mínimally invasive surgical vein and vascular treatments. With numerous clinics across Florida, Georgia, Colorado, Arizona, and Illinois, we have pos ...
-
Violence Recovery Specialist Iii
1 week ago
The University of Chicago Medicine Chicago, United States**Job Description**: · The **Violence Recovery Specialist-** Level III (VRS III) position part of the Violence Recovery Program (VRP), a hospital-based violence intervention program that provides support to those affected by community violence by acting as primary liaison to comm ...
-
2024-2025 Academic Counselor
1 week ago
Chicago High School For The Arts Chicago, United States**Responsibilities**: · - Counsel students on academic affairs · - Work with grade-level teams on tracking data · - Help coordinate interventions · - Meet with individual students as (Tier III intervention) · - Implement Behaviors Interventions and Support in coordination with th ...
-
Administrative Analyst Iii
9 hours ago
Cook County Health & Hospitals System Chicago, United States**ADMINISTRATIVE ANALYST III - ACHN** · **Job Number**: ** · **Job Posting**: May 16, 2024, 7:37:50 PM **Closing Date**: May 30, 2024, 11:59:00 PM · Full-time **Shift Start Time**: 8:30 A.M. **Shift End Time**: 4:30 P.M. · **Collective Bargaining Unit**: None · **Posting Salary** ...
-
Construction Manager Ii/iii
1 week ago
Anser Advisory Chicago, United StatesWe are looking for a highly motivated and passionate** Construction Manager II/III** to join our team in our growing Buildings division in K-12 facilities construction/modernization. In this role you will manage oversees and coordinate all facets of the pre-construction bid and a ...
-
Northwestern Medicine Chicago, United StatesThe **Pharmacy Technician Specialist** **reflects the mission, vision, and values of NM, adheres to the organization's Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation stand ...
-
Integration Manager
6 days ago
RoadSafe Traffic Systems, Inc. Chicago, United StatesThe integration manager is a pivotal member of the Corporate Development team who ensures the success of RoadSafe's acquisitions. Specific responsibilities (i) ensuring effective transitions from due diligence to integration (ii) planning and executing detailed integration plans; ...
-
Supervisor Aircraft Maintenance
1 week ago
Southwest Airlines Chicago, United States**Department**: Technical Operations · Our Company Promise · We are committed to provide our Employees a stable work environment with equal opportunity for learning and personal growth. Creativity and innovation are encouraged for improving the effectiveness of Southwest Airlines ...
-
Northwestern Medicine Chicago, United States**Are you a compassionate healthcare professional focused on providing exceptional care to your patients and the community?** · **Are you looking to take the next steps in your career in Specialty Pharmacy?** · **Are you seeking a day shift opportunity with no weekend commitment? ...
-
Men's Soccer Coach
1 week ago
Illinois Institute of Technology Chicago, United StatesCOMMUNICATIONS · CUSTOMER SERVICE · This position does not provide customer service to external customers and provides limited customer service to internal customers. · Special Schedule Requirements · Must be willing to work some nights and weekends · EEOC Statement · **Qualifica ...
-
Administrative Asst Iii
9 hours ago
City of Chicago Chicago, United States**Job Number**:396966** · **Description** · BID/JOB ANNOUNCEMENT · - Administrative Assistant III · - Office of Public Safety Administration · **Number of Positions: 2 (additional vacancies possible pending budget approval)** · **This position is open to the public and all curren ...
-
Administrative Asst Iii
2 days ago
City of Chicago Chicago, United States**Job Number**:393929** · **Description** · BID/JOB ANNOUNCEMENT · - ADMINISTRATIVE ASSISTANT III · **DEPARTMENT OF WATER** · **Number of Positions**:1** · **(Additional vacancies possible pending budget approval)** · **Salary: $58,956; Grade B-12** · **This position is open to t ...
-
Advanced Practice Provider
1 week ago
The University of Chicago Chicago, United StatesDepartment · BSD PED - Neonatology - Comer · About the Department · With a bed capacity of 71 beds, the NICU in Comer Children's Hospital is one of the largest Level III NICUs in Chicago and a major referral center for the sickest newborn infants with the most complex conditions. ...
-
Ems Educator
4 days ago
MedEx Ambulance Service Skokie, United States**EMS Educator** · **The EMS Educator develops and implements all aspects of instruction for Paramedic and EMT programs within the MedEx organization including New Hire Orientation**. · T**HE EMS EDUCATOR WILL**: · - W**ork with the Director of Education in coordinating teaching ...
-
Area Director
1 day ago
WM Lombard, United StatesAs an EEO/Affirmative Action Employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, or veteran status. · Waste Management (WM), a Fortune 250 ...
-
Rep Ii, Customer Service
4 days ago
APL Logistics Woodridge, United States**Overview**: · Customer Service Representative II is responsible for communications with customers in a professional, prompt, and effective manner which includes responding to inquiries, processing orders and handling complaints. _The CSR II addresses higher level non-routine cu ...
Clinical Research Coordinator III - Oak Park, United States - DM Clinical Research
Description
Job Description
Job DescriptionClinical Research Coordinator IIIA CRC III will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. To ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.
DUTIES & RESPONSIBILITIES
KNOWLEDGE & EXPERIENCE
Education:
Powered by JazzHR
vgm6fRJw4m