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Clinical Research Project Manager

Philadelphia, PA, US, 19146

​Location: LOC_ROBERTS-Roberts Ctr Pediatric Research 

Req ID: 181911

Shift: Days

Employment Status: Regular - Full Time 

​About Us
We’re seeking breakthrough makers! Children’s Hospital of Philadelphia was built on the belief that we can change lives. Today, in every role throughout our hospital, research institute and care network, the 22,000 members of our workforce are finding new ways – big and small – to make a difference for the patients and families we serve. 

If you are ready to challenge yourself, be inspired and grow – no matter what your role – you just may be the kind of breakthrough maker who will thrive at CHOP.

​CHOP is proud to share that we are ranked No. 1 on Forbes' 2022 list of America's Best Large Employers!

About the Minds Matter Concussion Frontier program:

The Clinical Research Project Manager position will function independently to manage a portfolio of concussion research projects that are part of the Minds Matter Concussion Frontier program. Within the project scope of work, participates in organizing and facilitating the day-to-day activities and long-term goals and objectives of the projects. PM will work with multiple interdisciplinary research and program teams, including physicians, researchers, community-based partners, and various clinical staff. PM supervises research coordinators, research assistants, and students. 

 

Primary responsibilities will include but not be limited to staff and student training and supervision, oversight of study operations and data management, and serving as liaison to community partners and collaborators. Additional responsibilities will include management of regulatory oversight, quality assurance, and support of grant submissions and manuscript development.

 

To learn more about this program visit: Minds Matter Concussion Frontier program

What you will do as a Clinical Research Project Manager:

 

Responsibilities include but are not limited to:
 

  • Works with PI to develop study protocols and translate protocols to standard operating procedures, supervises the implementation of and adherence to study protocols; educates research and clinical staff on established policies, processes, and procedures

  • Develop procedures to ensure that study enrollment and data capture activities are compliant with IRB regulations and sponsor guidelines and are being completed as outlined in protocols and grants

  • Audits study operations as part of regular quality assurance efforts; provides leadership in identifying and implementing corrective actions/processes

  • Determines effective strategies for promoting/recruiting research participants and retaining participants in long-term projects

  • Optimizes recruitment strategies in order to meet study enrollment and retention goals

  • Manages and oversees training activities of research coordinators, research assistants, and students

  • Acts as primary liaison for research investigators, IRB, community partners, and healthcare professionals in order to maintain relationships

  • Overseeing all aspects of study REDCap database to ensure that forms are working correctly, data is being saved and exported accurately, all relevant data fields are present, and updating the forms as needed

  • Assist in the development and submission of protocols, amendments, continuing reviews, and reportable events

  • Supports annual reporting efforts to study sponsors

  • Develop advertisement and promotional materials

  • Provide support to the Program Manager and Investigators

  • Attend and contribute to regular team meetings

  • Maintain Clinical Trial.gov 

Required Education and Experience

  • Bachelor’s degree

  • Two (2) years of relevant clinical research experience

Preferred Education, Experience & Cert/Lic

  • Master’s degree in related field

  • Three (3) years of relevant clinical research experience

Additional Technical Requirements

  • Responsible for overall management of the trial(s) to ensure compliance with study protocol, FDA, NIH and IRB policies. 

  • Applied knowledge of Good Clinical Practice (GCP) guidelines including protection of human research subjects with particular emphasis on pediatrics, definitions and reporting requirement for adverse events, elements of informed consent, Federal Codes, Regulations and Guidelines relevant to the performance and conduct of clinical trials.

To carry out its mission, it is of critical importance for the Children’s Hospital of Philadelphia (CHOP) to keep our patients, families and workforce safe and healthy and to support the health of our global community. In keeping with this, CHOP has mandated all workforce members on site at any CHOP location for any portion of their time be vaccinated for COVID-19 as a condition of employment.  This mandate also applies to workforce members performing work for CHOP at non-CHOP locations. Additionally, all workforce members based in or regularly scheduled to work at any New Jersey location are mandated to be both vaccinated and boosted for COVID-19, with booster timing consistent with applicable guidelines. The CHOP COVID-19 vaccine mandate is in alignment with applicable local, state and federal mandates. CHOP also requires all workforce members who work in patient care buildings or who provide patient care to receive an annual influenza vaccine. Employees may request exemption consideration for CHOP vaccine requirements for valid religious and medical reasons.  Please note start dates may be delayed until candidates are fully immunized or valid exemption requests are reviewed. In addition, candidates other than those in positions with regularly scheduled hours in New Jersey, must attest to not using tobacco products.
EEO / VEVRAA Federal Contractor

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