Clinical Research Program Manager
Responsible for assisting with the financial, administrative, operational, managerial, and human resources aspects of a research group in the Division of Adolescent Medicine. Manages all aspects of multiple small to large scale research studies, including supervising all research staff and rotating students. Works independently in accordance with established objectives and within institutional guidelines. Oversees various projects of clinical, epidemiological, health services, and/or behavioral research. Also may perform all CRC Core and additional responsibilities as detailed for CRC Level 1 through 4. The position will be conditional and duration will be based on the availability of grant funds to support this position.
This research group focuses on improving reproductive health outcomes among adolescent and young adult women, including managing web-based projects, secondary data analyses of large datasets, clinical trials, intervention design and evaluation, and quality improvement initiatives.
- Monitors progress of study activities (e.g. data collection and validation, recruitment, pilot studies, focus groups, etc.) and ensures that study objectives are met
- With the assistance of CHOP Human Resources, coordinates recruitment and onboarding of qualified research and support staff, non-physician professional and technical staff, including advertising, interviewing, selection, and training in accordance with CHOP’s Policy and Procedure manual
- Direct and indirect supervision, training, support, and management of staff to ensure compliance with study protocol, NIH, and FDA policies
- Assists with mentoring, developing, and training for undergraduate and graduate clinical and nonclinical trainees and research volunteers
- Provides supervision and support for clinical research staff who are assigned to specific protocols and who help with the overall clinical research of the program
- Provide a leadership role in developing, implementing, and evaluating the conduct of clinical research
- Works collaboratively and effectively with the individual study management teams, various core groups at CHOP’s Research Institute, the University of Pennsylvania, and other collaborating institutions
- As part of Management Team, develops, reviews, and updates program policies and procedures as needed
- Develops and implements study protocols/operation manuals, sometimes in conjunction with Project Research Coordinator(s) and Principal Investigator
- Serves as primary liaison between research and other hospital staff to carry out the needs of the research projects
- Makes decisions for day-to-day operations of projects including the resolution of technical problems and questions from project staff
- Assists with analysis of data and preparation of manuscripts and scientific presentations, as needed
- Applies 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
- Responsible for regulatory compliance for clinical research program
- Assists in developing budgets for research grants and initiatives within established timetables
- Manages and balances project budgets, in collaboration with the Research Business Manager
- Negotiates contracts with and oversees research and service subcontractors (e.g. collaborating investigators, web developers, instructional design experts)
- Manages pre- and post-award administrative responsibilities such as including identification of funding opportunities, grants preparation including budget, grant submission, grants accounting, monitoring and reconciliation, grant close outs and other grant related activities
- Collaborates with Marketing and Development to create promotional materials and identify potential funders
Required Education and Experience
Required Education: Bachelors of/in Arts/Science in related field
Required Experience: 8-10 years experience in clinical research. 3 years experience in research administration or managing a research group, including budget administration, financial planning, and grants management. 1-2 years supervisory experience.
Preferred Education, Experience & Cert/Lic
Preferred Education: Masters of/in Arts/Science in related field preferred.
Preferred Experience: 5 years experience in research administration or managing a research group, including budget administration, financial planning, and grants management. Experience in an academic institution strongly preferred. 3-5 supervisory experience in a clinical research environment preferred.
Additional Technical Requirements
- Must be able to meet deadlines, work on several projects at once, and understand all of the concepts involved in the work performed.
- Able to work collaboratively with adolescents who are research participants or patients and their families.
- Comfortable working on issues related to adolescent sexuality.
- Familiarity with adolescent and/or women’s health research.
- Familiarity with health services research, qualitative research methodologies, large dataset research.
- Experience with qualitative and statistical analysis software is preferred.
- Excellent personnel management skills.
- Excellent time management skills required. Must be able to work effectively with minimal direct oversight and manage multiple projects with varying deadlines for several individuals. Must be able to juggle multiple demands, work styles, and needs.
- Must have strong organizational skills, be able to work accurately, pay strict attention to detail, and be amenable to doing varied work that requires an intellectual and professional approach.
- Successful performance in a high-intensity work environment. Excellent problem identification and problem solving skills.
- Excellent written and interpersonal skills.
- Ability to handle confidential matters and materials.
- Evidence of leadership ability.
- Ability to work with sensitivity to cultural diversity and to assist staff in understanding this diversity.
- Travel to other study sites for multi-site studies and to collaborating institutions for data collection and meetings may be required.
- Evening and weekend work may be required.
Interested applicants can apply here.
PolicyLab at Children’s Hospital of Philadelphia (CHOP) is seeking an undergraduate intern to work with its communications team. PolicyLab is research center within Children’s Hospital of Philadelphia dedicated to achieving optimal child health and well-being by informing program and policy changes through interdisciplinary research. The communications team is responsible for translating PolicyLab research and policy recommendations to internal and external audiences through a variety of online and public relations tactics.
To assist the communications team with its goals, the Communications Intern will be responsible for:
- Drafting and scheduling tweets
- Drafting content for the PolicyLab website
- Writing bios of outside speakers and for other events
- Researching and recording media clips
- Contributing to strategic communications plans for translating and disseminating research
- Video editing and graphic design (experience not required but a plus)
Candidates should be rising sophomores or upper classmen who are currently studying communications, public health or related fields. An interest or background in health communications is required. Strong candidates must have good writing skills, social media experience and comfort with copyediting for research and lay audiences. The paid internship formally begins in May, with the option of beginning sooner, and continues through the summer and academic year. Interns can expect to work 15-20 hours per week.
Clinical Research Associate I
This is a full time research associate position offered through PolicyLab at the Children’s Hospital of Philadelphia. The aim of PolicyLab is to achieve optimal child health and well-being by informing program and policy changes through interdisciplinary research. Our research process is engaged with local, state, and national stakeholders from beginning to end, ensuring that our research provides insight that can meaningfully improve child health in the community. PolicyLab prides itself on cultivating professional growth and offering opportunities for research staff to apply their skills to impactful research.
The research associate will assume a lead role, under the direction and guidance of the Principal Investigator, in providing analytic and project coordination support for research activities in PolicyLab’s Intergenerational Family Services portfolio. In projects related to home visiting programs and child maltreatment in military families, the research associate would be responsible for quantitative analysis of large administrative datasets. The research associate will additionally collaborate with other research team members to translate and disseminate findings for a variety of audiences.
The ideal candidate will have specialized training in public health, including biostatistics and epidemiology, with a high degree of understanding of research project coordination. The research associate will need to exercise discretion and judgment in the oversight and management of research- identifiable data, extraction and analysis of data, general project support, and project dissemination activities. The research associate will oversee reporting requirements. Additionally, the ideal candidate will have excellent writing skills and the ability to clearly communicate findings to both research and policy audiences.
- Coordinates project activities and maintain communication with Principal Investigator and research team members.
- Plans and leads weekly meetings of team members.
- Performs data acquisition, compliance, and management activities to meet standards for federal and state administrative data.
- Collaborates with the data programming staff.
- Perform data analysis tasks in collaboration with Principal Investigator.
- Collaborates with the Principal Investigator to prepare dissemination of results as abstracts, scientific manuscripts, and progress reports.
- Prepares applications for the IRB or IACUC, Radiation Safety Committee, and other official regulatory groups. Keeps up-to-date files on correspondence and maintain approval status.
- Attends conferences and presentations to share project findings.
- Applies relevant project lessons and skills to ongoing center initiatives.
Masters of/in in Public Health or Epidemiology with 3 - 5 years of clinical research experience OR a PhD in a related field.
Additional Technical Requirements
- Proficiency in SAS or STATA
- Ability to function independently in a clinical research setting
- Ability to handle multiple, time dependent tasks
- Excellent communication skills to interact with staff, parents and children
- Ability to handle confidential materials
- Excellent organizational and analytical skills
- Ability to write progress reports and scientific manuscripts
- Ability to use computers, learn new software applications
- Ability to manage data and perform quantitative analysis
- Current knowledge and understanding of GCP and ICH guidelines as well as FDA and, if applicable, local regulations, Definitions and Reporting requirements for adverse events, IRBs, Elements of Informed Consent
For more information and to apply, click here.
Statistical Scientist I — Healthcare Analytics Unit
The Statistical Scientist I with the Healthcare Analytics Unit provides expert statistical support to an investigator and takes a leadership role in the development of a statistical programming and data analysis plan. He/she contributes original ideas and participates in all facets of research plan and conduct including research methods, preparation of data sets, sample size calculations, performance of statistical analysis, and interpretation of results, authorship and publication of original research projects. The Statistical Scientist I works under the directorship of an established principal investigator or faculty level statistician while participating in research on a wide variety of topics. He/she conducts work independently.
- Participates in the design of research projects and works under the direction of an established principal investigator or faculty statistician.
- Contributes expertise in the statistical design and planning of research projects.
- Reviews draft plans for feasibility and statistical appropriateness.
- Collaborates with project team to develop analysis plans, sample sizes, randomization schemes and apply appropriate methodologies.
- Independently develops plans for statistical programming, data management, creation of analytical data, and data evaluation.
- Provides leadership in implementation of analysis plan.
- Prepares accurate and meaningful reports of analyses including summary tables, charts, plots, and graphs and interpretation of results.
- Prepares data files for statistical analysis; ensures integrity of data using general tests for validity.
- Participates and provides expertise in the interpretation of research results.
- Contributes to manuscript and abstract writing and preparation for publications in peer-reviewed scientific journals.
- Participates in and provides expertise for statistical plans in the development of new grant proposals.
- Provides database review, statistical programming and data analysis consultation to project team members and colleagues in CHOP community.
- Performs other related duties as assigned or directed to meet the goals and objectives of the research group.
MS required in Statistics, Biostatistics, Mathematics, Computer Science, etc.
5-7 year’s relevant experience required; Ability to work efficiently on multiple projects required.
PhD preferred with minimum of 3+ years relevant experience
Demonstrated achievement in facilitating and proposing a research project.
Additional Technical Requirements
Advanced skills and knowledge in biostatistics, statistical methods in medical and clinical research, and clinical epidemiology.
5+ years of experience and proficient in base SAS, SAS/SQL, SAS/STAT, SAS/GRAPH and SAS MACROS, or other commonly used statistical languages.
Knowledgeable about database utilization in statistical analysis; familiar with UNIX and windows OS.
To apply for this position, please click here.
Clinical Research Assistant II
This is a full-time Clinical Research Assistant II position offered through PolicyLab at Children’s Hospital of Philadelphia (CHOP). The aim of PolicyLab is to achieve optimal child health and well-being by informing program and policy changes through interdisciplinary research.
PolicyLab is seeking a research assistant who has experience performing a variety of research tasks, such as subject recruitment, informed consent, completion of case report forms, chart abstraction, delivery of study interventions, database management, literature reviews, and assisting with IRB submissions. Initially the successful candidate will support a new grant funded initiative to conduct qualitative interviews with adolescent women to better understand their experiences during the first 6 to 12 months of using a new contraceptive method.
The successful candidate will work under the direction of Dr. Aletha Akers (Principal Investigator), an adolescent gynecologist and medical director of Adolescent Gynecology Consultative Services in the Craig-Dalsimer Division of Adolescent Medicine at CHOP and Assistant Professor of OBGYN and Pediatrics at the University of Pennsylvania. Dr. Akers is an expert in pediatric and adolescent gynecology. She provides clinical care to children, adolescents, and young women with complex gynecologic care needs. She has expertise in providing routine, preventive care and addressing the contraception needs of adolescents with medical problems and those at risk of unplanned pregnancy.
Dr. Akers’ research focuses on improving reproductive health outcomes among adolescent women by reducing teen pregnancy and sexually transmitted infection (STI) rates by increasing adolescents’ access to high quality reproductive health services. Her ongoing projects include: a clinical trial investigating pain management options during insertion of intrauterine contraceptive devices, a retrospective study of longitudinal datasets to understand sexual risk behaviors among obese adolescents, a prospective study exploring factors influencing IUD uptake and experiences among adolescent women, and pilot testing an adolescent-centered model of contraceptive clinical care services to reduce teen pregnancy.
Responsibilities of the Clinical Research Assistant include, but are not limited to:
- Assisting the Administrative Director of Research, Clinical Research Coordinators, and Principal Investigator in all aspects of projects
- Assisting with IRB submissions such as creating or editing protocols, applications, and informed consent forms
- Performing medical chart reviews
- Helping create and manage survey instruments and databases in SurveyMonkey, REDCap, and other platforms as needed
- Recruiting study participants, including by email, telephone, and face-to-face meetings
- Conducting research interviews and questionnaires, including face-to-face and telephone interviews
- Scheduling study visits and coordinating participant incentives
- Participating in the informed consent process and conducting study visits
- Meeting all quality assurance and confidentiality guidelines for data collection, and ensuring accurate completion of questionnaires and other data collection during study visits
- Ensuring compliance with all data management and data security protocols
- Collecting/entering, cleaning, and analyzing study data
- Conducting literature searches and maintaining endnote libraries
- Assisting with supervising student employees
- Assisting with the preparation of manuscripts and publications
- Assisting with administrative tasks as needed, such as ordering supplies
- Assisting with research dissemination activities, including developing and managing content for research webpages
- Attending weekly meetings of the CHOP research team and other pertinent project or division related meetings
Required Education and Experience:
- Required Education: AA in a related field
- Required Experience: 2+ year(s) relevant clinical research experience
- Preferred Education, Experience & Cert/Lic
- Preferred Education: BA/BS in a related field
- Preferred Experience: Conducting research interviews and performing qualitative coding; Experience with survey/data management software, such as REDCap
Additional Technical Requirements:
- Proficiency in MS office
- Ability to pay strict attention to detail
- Ability to function with minimal supervision in a clinical research setting
- Ability to work collaboratively as a member of the study team
- Excellent communication and interpersonal skills to interact with staff, adolescents, and community partners
- Ability to be discreet with confidential materials and sensitive topics
- Ability to handle multiple, time dependent tasks in a fast paced, complex work environment
- Adaptable to do work which is varied and requires an intellectual and professional approach
- Ability to be flexible with work hours to accommodate scheduling needs of the study
Please apply through the CHOP Careers page.