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Job Title: Clinical Research Regulatory Spec-Center for Autism Research (CAR)
Job Number: 18450
Organization: Children's Hospital of Philadelphia
Posted: 4/10/2018
Type: Full-Time
Number of Openings: 1
Location: Philadelphia,  PA    USA
Position Description: Job Description Req ID: 18450

Shift: Days

Employment Status: AF - Active - Regular - Full Time

Job Summary

The Center for Autism Research (CAR) is conducting a wide range of studies seeking to identify the causes of autism spectrum disorder (ASD), and to explore effective interventions and other supports for families throughout the region who are affected by ASD. Working at CAR provides the opportunity to be a part of innovative, break-through research on a complex developmental disorder that affects 1 in 68 people in the United States. Most studies at CAR involve behavioral evaluations, brain imaging, interventions, and/or genetics, and are aimed at explaining the underlying mechanisms of this complex disorder.

Job Summary

The Clinical Research Regulatory Specialist assumes a central, key supportive role for all studies conducted under the auspices of the Center for Autism Research (CAR). This position is responsible to assist with the writing, review, and submission of all study protocols, amendments, informed consent documents, annual reviews and safety reports to the CHOP IRB. This position will also serve as a central resource for all CAR staff for all human subjects regulatory matters and may provide training and support to CAR staff to ensure compliance with study protocols, federal regulations, and CHOP, CHOP IRB, NIH, and FDA policies.

Job Responsibilities

Write protocols, informed consent forms, and other study documents for submission to the IRB

Amend studies and update study staff list as necessary

Submit continuing reviews and study updates to the IRB as required

Maintain approved IRB documents for all studies

Monitor active and non-active studies to ensure that studies are in compliance regarding enrollment numbers, consent documentation, study staff training, etc.

With CAR’s Data and Statistics Core, ensure that studies are collecting and storing data according to the study protocol and applicable policies

Serve as the liaison between CAR and other groups within the Research Institute (e.g. IRB, CHPS, PeRC, COI, REC)

Provide support, guidance, and training for research staff in matters of human subjects protection and compliance

Provide guidance in the development, implementation, and evaluation of the conduct of clinical research

Work collaboratively and effectively with individual study teams, collaborators, and other institutions

Keep abreast of changes to CHOP policies (including IRB policies) as well as federal regulations

Attend trainings offered by the IRB, Office of Research Compliance, or other organization, either in-person or online

Qualifications: Required Education and Experience

Bachelor’s Degree with minimum 5 -7 years clinical research experience or a Masters Degree in Public Health (or related field) with at least 3-5 years clinical research experience or an RN with at least 5 years clinical research experience. Minimum of 2 years experience in pediatric clinical research.

Preferred Education, Experience & Cert/Lic

Bachelor’s Degree with minimum 5-7 years clinical research experience, or a Master’s Degree in Public Health (or related field) with at least 3-5 years clinical research experience

Minimum of 2 years experience in pediatric clinical research

Additional Technical Requirements

Skills and knowledge of federal policies (i.e., Common Rule) and regulations pertaining to clinical research, ICH GCP, HIPAA at a level sufficient to function independently as a consultant to CAR personnel.

Ability to manage multiple protocols with varying deadlines for multiple investigators.

Ability to handle confidential matters and materials.

Ability to work effectively with minimal direct oversight.

Knowledge of pediatric clinical research

Excellent written and oral communications skills. Practices attentive and active listening.

Excellent time management skills with ability to independently prioritize, organize and efficiently deal with a multiple ongoing activities

Must be mature, self-motivated and responsible; must be able to initiate and complete routine and non-routine tasks

Demonstrated ability to work as an effective leader and team member

Excellent time management skills with ability to independently prioritize, organize and efficiently

Organization Description: All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.

Children's Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children's Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products or nicotine in any form and a negative nicotine screen (the latter occurs after a job offer).

Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.

VEVRAA Federal Contractor/Seeking priority referrals for protected veterans. Please contact our hiring official with any referrals or questions.

CHOP Careers Contact

Talent Acquisition

2716 South Street, 6th Floor

Philadelphia, PA 19146

Phone: 866-820-9288

Closing Date: 7/10/2018
Desired Starting Date:
Contact Name: Heather Warman,  Clinical Research Regulatory Spec-Center for Autism Research (CAR)
Contact Location: 2716 South Street, 6th Floor

United States
Contact Location: 2716 South Street, 6th Floor
  United States
Contact Phone:  
Contact Fax:
Contact Email:
Web Address:
How to Apply: Apply directly: Clinical-Research-Regulatory-Spec-Center-for- Autism-Research-%28CAR%29-PA- 19146/468202900/?utm_source=emory

Additional Information:

Web Site Delete Date: 7/10/2018