Research Coordinator

Philadelphia Fight•Philadelphia, PA

8d•Onsite

About The Position

We're seeking our next Research Coordinator to help support the incredible work of Philadelphia FIGHT's Research Department. Our Research Coordinator's manage the day-to-day operations of research studies, ensuring protocols are followed and data is collected accurately. This role will involve recruiting participants, conducting study visits, documenting all activities in accordance with ALCOA-C principles, and maintaining regulatory compliance. The coordinator will work closely with investigators and patients to support high-quality, ethical research outcomes.

Requirements

Bachelor's Degree in a science- or public health-related field required
2+ years' experience of professional research (including internships and volunteer work) required
General knowledge of science, medical terminology, record maintenance, and data entry.
Must possess basic computer skills to perform job duties including desktop computing, e-mail, timesheet management, reporting, etc. using relevant software such as iMedidata/Rave, Interactive Response Technology (IRT), REDCap, Electronic Medical Records and Microsoft Word, Excel, etc.
Demonstrated ability to understand the overall purpose of research and function of the Institutional Review Board and regulatory obligations including informed consent, confidentiality, study specific procedures, etc.
Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and excellent customer service.
Ability to demonstrate cultural competency and understanding of a trauma-informed, harm-reduction approach to health care.
Ability to remain organized and analytical.
Must be able to exercise good judgment and identify when to escalate issues as appropriate.
Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices such as OSHA, HIPAA, CLIA and funding body regulations.
Excellent verbal and written communication skills required.
Strong skillsets in interpersonal relationships and teamwork, attention to detail, customer service, time management, integrity, autonomy and problem solving.
Discretion, initiative, and ability to maintain HIPAA compliance and PA Act 148 compliance.

Nice To Haves

graduate degree (MA/MS, MPH, RN, etc.) preferred.

Responsibilities

Conducts FIGHT research consistent with FIGHT operational procedures and/or regulatory guidelines and established federal (21 CFR§50, GCP Section 4, etc.), state and local law.
Conducts phlebotomy and blood processing related tasks, including shipment and transport of clinical samples.
Completes source documentation and ensures Case Report Form are completed in accordance with FIGHT Research Standard Operating Procedures (SOPs).
Timely and accurately completes all documentation assigned, including source documentation in study or clinic charts, collected of Informed Consent Form including ICF checklists, electronic case report forms and data entry; resolves and responds to queries from the study sponsor and regulatory agencies in a timely manner under the direction of the Research Director, with mentorship from Sr. Coordinator.
Attends and participates in Investigator Meetings under the direction of the Research Director (in person or virtually) to be trained on new clinical trials.
Reports AEs, SAEs, and Special Situations in accordance with clinical trial agreements, FIGHT Research SOPs, and ICH GCP, to the PI and Research Director for timely submission to the FIGHT IRB, study sponsor, and any applicable federal regulatory agencies.
Coordinates the scheduling of research patients with the medical providers; reports progress of clinical care to PI and Sub-PIs as needed.
Develop source visit worksheets in alignment with individual protocol tables of events.
Completes drug receipt confirmation, dispensation, administration, and accountability per individual study guidelines.
Collects vital signs, anthropometric measurements, questionnaires, and other assessments as outlined in study protocols.
Maintains study logs (including electronic, screening and enrollment logs) and regulatory binder as directed by the Research Director.
Participates in patient recruitment, including pre-screening charts and reaching out to potentially eligible participants by telephone, email, or text.
Maintains communication and professional rapport with study participants to ensure high percentage of participant retention, either by phone, email, or text, (as per patient/subject preference).
Demonstrates commitment to Good Clinical Practices, maintenance of confidentiality, and informed consent.
Documents all activities related to patient care appropriately in the Electronic Medical Record and within the established timeframe set forth by FIGHT policy and by FIGHT Research SOPs.
In parallel with Research Director and Sr. Research Coordinator, receives temperature monitoring alerts for study drug cabinet and ultralow specimen freezer.
Assists in the coordination and monitoring of inventory and supplies; reports items in low stock to Director in a timely manner.
Receives and addresses participant feedback; reports feedback to Director – Research as appropriate.
Resolves all data queries in a timely manner in accordance with clinical trial agreements and FIGHT Research SOPs.
Reports protocol deviations/violations to the Director for reporting to the PI, IRB, and Sponsor in a timely manner and in accordance with clinical trial agreements and FIGHT Research SOPs.
Assesses the physical plant, including laboratory station, supply closets, and drug cabinet on a routine basis, ensuring that the space is neat and clean, reports safety hazards, maintenance or facilities problems promptly.
Prepares all mandatory reports accurately and in a timely manner.
Participates in site initiation, monitoring, and close-out visits and provides assistance to study monitors/auditors.
Abides by all compliance standards including but not limited to completing training and attending all required staff meetings, supervision meetings and/or daily huddles.
Upholds and ensures compliance and attention to all FIGHT policies and procedures as well as the overall mission and values of the organization.
Other duties as assigned to fulfill FIGHT's mission.

Benefits

3 weeks of PTO (4 weeks after 1st year)
11 paid holidays
Comprehensive Medical, Dental, Vision & Prescription Coverage
Employer-funded Short-Term Disability coverage and Life & Accidental Death and Dismemberment (AD&D)
Flexible Spending Accounts (FSA) and Health Reimbursement Arrangements (HRA) with employer contribution
403(b) Retirement Savings Plan with options for basic plan or Roth 403(b) contributions with employer matching up to 4%
Discounted education options with partnered institution Pierce College
option to contribute to medical discount programs
legal services
charitable contributions
pet insurance coverage