Germantown - Silver Spring, Maryland
Location: Baltimore, Maryland
Internal Number: 108483-en_US
We are seeking a Sr. Research Coordinator who will work as part of the Division of Clinical Pharmacology Drug Development Unit and will support clinical studies sponsored by pharmaceutical companies, government agencies, and Johns Hopkins investigators. Subject populations involved in the studies include healthy adults and various populations with disease.
The person in this position will:
- Work on multiple complex clinical studies which require a high level of knowledge, coordination and data abstraction
- Maintain detailed knowledge of all assigned protocols, adhere to all protocol requirements to ensure the validity of the clinical research data, and transmit/distribute protocol information as needed
- Interact with faculty, fellows, and staff of various divisions/departments of the Johns Hopkins School of Medicine.
Specific Duties & Responsibilities
- Assist investigators in defining information and plans required to accomplish goals of the clinical trials.
- Prepare essential documents and maintain a binder and data base of IRB submissions for protocol initiations, annual renewals, further study actions, adverse events, and progress reports according to IRB and sponsor requirements.
- Develop and maintain a protocol database and spreadsheets for tracking patient activity, financial management and data analysis.
- Prepare and maintain study specific data base and documents for research charts e.g. source documents and case report forms when these are not supplied by a sponsor.
- Perform subject recruitment; develop advertising and recruitment materials, post flyers, and place advertisements in newspapers, websites, or other venues as determined by study team.
- Complete and maintain up to date documentation of human subjects, research training required by the JHM IRB, DDU, and protocol Sponsors including and not limited to: JHM Research Compliance, HIPAA, Bloodborne Pathogens, and CPR.
- Inform potential study subjects about research studies, procedures, and protocol requirements.
- Explain the informed consent process to subjects, obtain, and document subject informed consent.
- Conduct screening interviews and administer screening questionnaires.
- Collect study required data from patients, charts, electronic databases, clinical and research laboratories, imaging services and other sources.
- Assess eligibility of potential study subjects comparing patient history and clinical laboratory results with study specific inclusion and exclusion criteria.
- Enroll eligible subjects into studies and provide eligibility source documentation for all patients enrolled in the study.
- Maintain study subject rosters to track and document status of subjects and complete screening, enrollment, completion, dropout, and termination information reports.
- Provide patient education as needed to enhance subject safety and compliance with study.
- Prepare orders and perform protocol-specific in-service training for nursing staff and scheduled admissions on the inpatient Clinical Research Unit (CRU Osler 5).
- Order and inventory clinical supplies necessary for performance of studies.
- Assemble PK kits and admission documentation to be supplied for inpatient CRU study visits.
- Schedule subjects for admissions, appointments, tests, and follow-up visits at the appropriate time to assure completion of protocol requirements.
- Coordinate and complete subject study visits according to study protocol to include vital signs, ECGs, phlebotomy, obtaining clinical samples, and performing health assessments.
- Design and compile materials which aid physicians and other staff in complying with protocol requirements for these visits and tests.
- Collect, compile, and maintain data in a research chart for each patient from a variety of sources.
- Organize and enter subject and protocol data into DDU Volunteer, study roster, and other databases.
- Communicate with laboratories or investigators regarding laboratory findings.
- Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
- Monitor to confirm accuracy and timeliness of protocol procedures and data entries so that data information may be used for presentations and publication.
- Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
- Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
- Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
- Respond in a timely manner to special projects or queries related to the data.
- Manage and document subject remuneration per IRB approved protocol specific plan and DDU SOP.
- Oversee personnel who may be assisting with any of the above duties.
- Meet regularly with Principal Investigators, Associate Director, or Sr. Research Nurse to review data accuracy and overall study progress.
- Prepare reports on individual patients and descriptive statistics for the protocol as required by the Principal Investigator or Sponsor.
- Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
- Meet with clinical trial financial management staff as needed to identify procedures, laboratory tests and protocol events that require invoicing to the sponsor as defined in the financial contract.
- Participate in relevant DDU, protocol, sponsor, and Clinical Pharmacology meetings as required to remain current and increase knowledge of clinical trials.
- Attend and participate in weekly staff and division meetings, protocol and research related meetings and trainings, performance improvement and quality assurance activities, and other meetings as required or assigned.
- Be willing and available for travel to research and study related meetings if deemed necessary by the PI.
- Be available to work evenings and/or weekends per study requirements if scheduled in advance.
- Take responsibility for completing tasks within specified timeframes.
- Communicate with others in the DDU and the division to express ideas, make suggestions, seek help as necessary, and to work as part of a team.
- Understand and adhere to schedules, protocols, and Standard Operating Procedures (SOP).
- Demonstrate an ability to work well with a diverse professional team and with minimal supervision. Exercise professional judgment and assume responsibility for own decisions, actions, results and consequences.
- Additional duties may be required that are not yet identified.
- Fully participate in manuscript development and preparation including, (1) pulling pharmacokinetic data from the clinical and laboratory databases, (2) at the direction of the study PI, analyzing PK data using WinNonLin and creating graphs/figures using Sigmaplot to display the data, (3) engaging in development of conference abstracts and presenting poster and oral presentations at scientific meetings where appropriate, and (4) writing and assisting with drafts of study manuscripts and preparing manuscripts for journal submission
- Oversee data management activities for investigator-initiated research protocols conducted in the DDU, including (1) reviewing the study protocol with the PI to identify the data points to be collected and assist the investigator with development of a data management plan, (2) designing and validating REDCap research databases and troubleshooting database issues, (3) leading efforts among the DDU team on data preparation, training staff on data entry, transfer, maintenance and archiving, (4) developing and preparing data for analysis at the direction of the study PI, as well as preparing summaries for clinical trial reporting (ie Clinicaltrials.gov, progress reports, DSMB meetings) (5) Working with the DDU Director and Nurse Practitioner Manager as needed to develop Standard Operating Procedures (SOPs) and Study Specific Procedures (SSPs) related to data entry and management.
- Under the direction of the DDU Nurse Practitioner Manager, lead the DDU team in creating across the board strategies for study recruitment to support protocol enrollment, including the following: (1) drafting and implementing an online registry (i.e. IRB approvals, tool development, and database maintenance. (2) developing novel recruitment advertising strategies for social media, (3) identifying resources to improve participant participation and retention (i.e. arranging transportation, advocating for dependent care support).
- Maintain inventory management of supplies for the DDU clinical areas, including the following (1) monitoring stock expirations to minimize waste (2) timely planning and coordinating new supply orders (3) stocking supplies in the practice of first in first out (FIFO) when expiration date applies. (4) ensuring good storage practice guidelines (i.e. not storing on the floor, acceptable temperatures are maintained, etc.)
- Bachelor's Degree in related discipline. Related Master's preferred.
- Five years related experience
- Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula
- Current CPR certification required.
- Demonstrated supervisory or lead responsibilities.
- Proven experience and successful work history in a comparable clinical trials research environment.
- Knowledgeable of and compliant with the Code of Federal Regulations Title 21-Good Clinical Practice Parts, 11, 50, 54, 56, and 312; with the International Conference on Harmonisation Good Clinical Practice Guideline (E6); and with the policies and guidelines of the Johns Hopkins medicine IRB, and SOPs of the DDU and clinical trial sponsors.
- Demonstrated organizational and time management skills with a high degree of attention to detail.
- Ability to manage multiple and competing priorities.
- Proficiency working with computers and various software applications, especially Microsoft Excel and Microsoft Word, the World Wide Web and electronic mail.
- Phlebotomy experience.
- Certification as a SOCRA or ACRP Clinical Research Coordinator preferred.
- Work produced is subject to precise measures of quantity and quality.
- Near vision to see objects clearly within 20 inches.
- Sharp focus to adjust vision when doing close work that changes in distance from eyes.
- Full spectrum vision to identify and distinguish color.
- Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
- Handling by seizing, holding, grasping, turning or otherwise working with the hand or hands, but without finger dexterity.
- Occasionally lifting, carrying objects weighing 20 lbs. or less.
- Occasionally pushing, pulling objects weighing 20 lbs. or less.
- Ability to move about without restriction.
Classified Title: Sr. Research Program Coordinator II
Starting Salary Range: $46,560 - $64,100 - $81,650 annually (Commensurate with experience)
Employee group: Full Time
Schedule: Monday-Friday, 8:30am-5:00pm
Exempt Status: Exempt
Location: School of Medicine - East Baltimore Campus
Department name: SOM DOM Clinical Pharmacology
Personnel area: School of Medicine
The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.
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