Study Manager I

3 weeks ago

Philadelphia, United States CareerBuilder Full time

Study Manager - Bilingual Spanish Required
A

Study Manager

is responsible to 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. In addition, ensure study enrollment meets or exceed Sponsors' expectations and company goals are achieved on a timely basis.

DUTIES & RESPONSIBILITIES
Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis.
Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
Adherence and compliance to the assigned protocols at their respective site(s).
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.

Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s).
Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s).
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)
Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner.
Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner.
Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation.
Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines.
Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s).
Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial.
Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents.
Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site.
Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned.
Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
Strive to ensure weekly, monthly and quarterly assigned goals are met for 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
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.

KNOWLEDGE & EXPERIENCE
Education:
High School Diploma or equivalent required
Bachelor's degree preferred
Foreign Medical Graduates preferred
Experience:
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
Bilingual in Spanish Required
Credentials:
ACRP or equivalent certification is preferred
Knowledge and Skills:
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 required
Powered by JazzHR

#J-18808-Ljbffr

  • Study Manager I

    3 weeks ago

    Philadelphia, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionStudy Manager - Bilingual Spanish RequiredA Study Manager is responsible to 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. In addition, ensure study enrollment meets...

  • Study Manager I

    2 weeks ago

    Philadelphia, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionStudy Manager - Bilingual Spanish RequiredA Study Manager is responsible to 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. In addition, ensure study enrollment meets...

  • Project Manager I

    5 days ago

    Philadelphia, United States Drexel University Full time

    **Job no**: 503116 **Work type**: Full-Time **Location**: University City - Philadelphia, PA **Categories**: Drexel University, Dornsife School of Public Health **Job Summary** The Project Manager will provide support to Dr. Alexis Roth in the Community Health & Prevention Department. As a member of an interdisciplinary team, the Project Manager will...

  • Industry Liaison

    3 weeks ago

    Philadelphia, United States ECOG-ACRIN MRF Full time

    Job DescriptionJob DescriptionIndustry Liaison (Oncology Studies)Summary: Working under the direction of the Senior Director, Clinical Research, the Industry Liaison will be responsible for assisting with liaison activities between ECOG-ACRIN Medical Research Foundation (“EAMRF”) and our pharmaceutical industry partners during all stages of a clinical...

  • Assistant to The Dean of Liberal Studies

    4 weeks ago

    Philadelphia, United States Community College of Philadelphia Full time

    Assistant to the Dean of Liberal Studies provides administrative support to the Dean, including organizing and maintaining the Dean’s calendar, coordinating the work flow for the Division, and supervising the Division’s office administrative assistants. The position responds to various types of inquiries across College departments and divisions.**College...

  • Clinical Project Manager

    2 weeks ago

    Philadelphia, United States Coalition of Cancer Cooperative Groups Full time

    Job DescriptionJob DescriptionSeeking full-time Philadelphia-based Project Manager who will serve and assist the organization’s Executive Director/Vice President in the development, implementation, and management of research activities as well as other related projects and programs.  Great opportunity for an experienced Oncology Study PM.Key...

  • Clinical Project Manager

    3 weeks ago

    Philadelphia, United States Coalition of Cancer Cooperative Groups Full time

    Job DescriptionJob DescriptionSeeking full-time Philadelphia-based Project Manager who will serve and assist the organization’s Executive Director/Vice President in the development, implementation, and management of research activities as well as other related projects and programs.  Great opportunity for an experienced Oncology Study PM.Key...

  • Account Manager

    3 weeks ago

    Philadelphia, United States EPLAN USA Full time

    Job DescriptionJob DescriptionAccount ManagerEfficient Engineering is when a PLAN becomes EPLANEPLAN LLC provides software and service solutions in the fields of electrical, automation, and mechatronics engineering. The company develops one of the world’s leading design software solutions for machine and panel builders. We continually evolve the business...

  • Kindergarten General Studies Teacher

    2 weeks ago

    Philadelphia, United States Philadelphia Hebrew Day School Full time

    Philadelphia Hebrew Day School is seeking a dynamic, creative and passionate **Kindergarten General Studies Teacher** for the 2024-2025 school year. Qualifications and Requirements: - BA or MA degree in Elementary or Early Childhood Education - Training in teaching literacy to young learners - Truly love teaching - Be flexible and positive - Be prepared to...

  • Online Arabic

    4 weeks ago

    Philadelphia, United States TeacherOn.com Part time

    I wish to master ArabicLevel: Intermediate Gender Preference: NoneMeeting options: Available online - via skype etc.

  • Ambulatory Nurse I

    7 days ago

    Philadelphia, United States Penn Medicine Full time

    **Description** Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all...

  • High School Social Studies Teacher: SY 2024-25

    3 weeks ago

    Philadelphia, Pennsylvania, United States Girard College Full time

    About Girard College: Girard College is a full scholarship boarding school that fosters intellectual curiosity, social development and emotional growth in academically focused students from underserved communities. We ensure every student the opportunity and the means to achieve excellence and preparation for advanced education through purposeful academic...

  • Founding 6th Grade ELA/Social Studies Teacher

    7 days ago

    Philadelphia, United States Hebrew Public Full time

    Job DescriptionJob DescriptionFounding 6th Grade ELA/Social Studies TeacherStart Date: Summer 2024Location: PHP (3300 Henry Avenue, Philadelphia, PA)Contact: jobs@hebrewpublic.orgNetwork Website: www.hebrewpublic.orgSchool Website: www.philadelphiahebrewpublic.orgAbout the Organization:Hebrew Public Charter Schools for Global Citizens. Our mission is to lead...

  • WMS Analyst I

    4 weeks ago

    Philadelphia, United States DHL Supply Chain Full time

    WMS Analyst IAre you a tech-savvy problem solver with a passion for optimizing warehouse management systems? Do you love analyzing data and collaborating with cross-functional teams to deliver top-notch results? If you're nodding your head "yes" to these questions, then we want YOU!As our WMS Analyst I, you'll be our go-to guru for implementing and...

  • High School Social Studies Teacher: SY 2024-25

    2 weeks ago

    Philadelphia, Pennsylvania, United States Girard College Full time

    Girard College is a full-scholarship boarding school that fosters intellectual curiosity, social development and emotional growth in academically focused students from underserved communities. We ensure every student the opportunity and the means to achieve excellence and preparation for advanced education through purposeful academic and residential...

  • WMS Analyst I

    3 weeks ago

    Philadelphia, United States DHL Supply Chain Full time

    This is an on-site second shift (2pm-10pm) role. WMS Analyst IAre you a tech-savvy problem solver with a passion for optimizing warehouse management systems? Do you love analyzing data and collaborating with cross-functional teams to deliver top-notch results? If you're nodding your head "yes" to these questions, then we want YOU!As our WMS Analyst I, you'll...

  • Service Desk Agent I

    1 week ago

    Philadelphia, United States Philadelphia College of Osteopathic Medicine Full time

    Job Title: Service Desk Agent I Department: Information Technology Services Location: Philadelphia Employment Status: Full Time, Non-Exempt Position Summary: The Service Desk Agent I serves as the primary contact for the MIS/Telecommunications Department, providing essential assistance to PCOM staff, faculty, and students with basic computer-related...

  • Service Desk Agent I

    13 hours ago

    Philadelphia, United States Philadelphia College of Osteopathic Medicine Full time

    Job Title: Service Desk Agent I Department: Information Technology Services Location: Philadelphia Employment Status: Full Time, Non-Exempt Position Summary: The Service Desk Agent I serves as the primary contact for the MIS/Telecommunications Department, providing essential assistance to PCOM staff, faculty, and students with basic computer-related...

  • Research Project Manager, Penn Nursing

    2 days ago

    Philadelphia, United States University of Pennsylvania Full time

    University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities...

  • Higher Education Content Strategist + Copywriter

    3 weeks ago

    Philadelphia, United States GPRS Full time

    Job DescriptionJob DescriptionOver the past 20 years, GPRS has built a national reputation in the higher education industry for its innovations, lead generation and digital marketing services, and proprietary media tracking and measurement platform – GP Insights(TM). SummaryGPRS is looking for an experienced, freelance, higher education content strategist...