Pulmonary and Critical Care Medicine is seeking a Senior Research Program Coordinator (SRPC) who will work under the direct supervision of the Program Manager or the Principal Investigator and will be an integral member of the investigational study team coordinating clinical studies in accordance with the protocol and investigator. The SRPC will participate in the recruitment and screening of research participants. Design and maintain organizational tools to conduct the research study accurately in compliance with good clinical practice guidelines. Responsible for coordinating and organizing the research participant study visit, collect, prepare and submit regulatory documents. Attend and participate in investigator meetings, seminars and other regional or national research meetings. Prepare and participate in study monitor site visits. Assist investigator in obtaining proper written consent and HIPAA from each study participant according to FDA guidelines.
The SRPC will perform functions necessary for completion of all research protocols including screening, scheduling, patient enrollment, medical histories, laboratory-phlebotomy and processing, specimen/data collection, follow-ups, and overall organization and logistics of study visits. Complete and correct case report forms ensuring accuracy of all records connected with each research participant. Complete accurate source documents and communication records. Report and record all adverse events according to Institutional IRB and the request of the sponsor. Knowledgeable of protocol so that all study activities are correctly completed. Maintain accurate record of all study supplies including lab kits, medications and other items dispensed to patients. Maintain close contact with each sponsor or pharmaceutical company concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse events. Perform other duties as required.
Specific Duties & Responsibilities:
Maintains good working knowledge of all assigned protocols and reporting requirements. Works on complex clinical studies which require a high level of knowledge, coordination, and data abstraction. Transmits and distributes protocol information.
Screen, recruit, and consent study subjects in both inpatient and outpatient settings with successful retention rates. Coordinate participant visits and follow-up, schedule appointments with study participants, make telephone reminders, send recruitment letters, track and locate participants. The SRPC will conduct all study visits from enrollment to study completion.
Recruit and screen potential study participants according to protocol's inclusion and exclusion criteria; be knowledgeable of the protocol so that study activities are completed correctly and completely.
Ensure that proper written informed consent from each study participant is obtained prior to entering study; ensure that the original signed and dated consent from each study participant is filed in participants' research record.
Perform vital study procedures such as venipuncture, collection of vital signs, spirometry, and biospecimen processing.
Design and maintain organizational tools to conduct the study accurately and in compliance with good research practice. Will develop and maintain a protocol database or spreadsheet for tracking patient activity, financial management and data analysis as needed. Collects, enters and compiles clinical data from a variety of sources. Ensures accuracy and timeliness of data so that information may be used by the physician in treatment planning, presentations, and publication. Maintain organizational tools to conduct the study accurately and in compliance with good research practice – manage regulatory binders, files, and participant study binder documents.
Verifies scheduling of patient appointments, tests, and follow up visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements. May design and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests.
Maintains regulatory binder for each assigned protocol. Prepares and submits annual renewal requests, amendments, and adverse event reports with clinical input according to IRB and Sponsor requirements. Adheres to all protocol requirements to ensure the validity of the clinical research data. May assist the principal investigator and research manager in defining information and plans required to accomplish goals of studies. Will design and create protocol specific case report forms as needed. May also assist less experienced staff in design and creation of such forms.
Provide assistance to the research manager and principal investigator in tasks relating to IRB submissions: completing progress reports, tracking of renewal dates, completing adverse event forms, writing draft forms. The SRPC will be responsible for creating, maintaining, and managing all regulatory matters appropriately with the IRB.
Work independently and under the direction of the manager to ensure successful completion of each clinical research study.
Conduct interviews over the phone or in person to determine eligibility for a research study.
Assist in developing and maintaining appropriate databases for current and future studies.
Maintain inventory of study related supplies. General maintenance of the laboratory, equipment, supplies, storage, shipping and receiving of specimens and transport of specimens if necessary.
Prepares for and participates in monitoring and audits of studies. Corrects errors in database when necessary. Writes responses to audit reports with input from the Principal Investigator.
Assists in training and supervising less experienced personnel.
Assist in the writing of post study data results and findings.
Efficiently use systems for complete study responsibilities – EPIC, CRMS, RedCap.
Mange electronic data capturing systems, complete all data entry to for both sponsor-initiated trials and investigator-initiated through different mechanisms including RedCap.
Attend and participate in weekly meetings to report on recruitment progress and resolve any research problems. Meet with Manager regularly to discuss studies as well as the training and progress of less senior staff.
Scope of Responsibility:
Knows the informal policies, procedures and practices necessary to conduct the normal function of a specific section, unit, or work area. Is aware of the role of the position and its potential impact on the working unit.
Carries out duties and responsibilities with limited supervision, but asks for clarification when needed regarding data quality and integrity issues and promptly notifies supervisors of any potential concerns regarding interactions with patients.
Will work directly under the supervision of the Principal Investigator and/or Research Program Supervisor.
Does not direct the activities of staff. Assists Research Program Manager with supervision and training of less senior staff.
Excellent verbal communication skills and good written communication skills.
Minimum Qualifications (Mandatory):
Bachelor's Degree in related discipline.
Three years in progressively related experience.
Additional education may substitute for experience due to JHU equivalency formula.
Master's Degree in related field.
Training in research coordination and/or management.
Special Knowledge, Skills & Abilities:
Position requires flexibility.
Ability to work independently and manage multiple tasks, detail oriented, self-motivated, strong interpersonal skills.
Ability to use personal computer; proficiency in Microsoft Word and Excel; database and spreadsheet knowledge.
Excellent oral and written communication skills and interviewing techniques required.
Strong interpersonal skills and excellent organizational and time management skills required.
Proficiency in the use of software applications, databases, spreadsheets, and word processing required.
Excellent organizational skills required.
Excellent attention to detail skills required.
Knowledge of medical terminology required.
Familiar with medical procedure and laboratory fees.
Ability to manage multiple and competing priorities.
Knowledge of clinical research practices and principles required.
Ability to understand a clinical trial financial contract.
Must have excellent time management skills.
Must have excellent oral and written communication skills.
Technical Qualifications or Specialized Certifications:
Standard HIPAA courses must be completed and appropriate exams passed with necessary certification within 2 weeks of start date.
Sitting in a normal seated position in office setting.
Standing and/or walking for extended periods of time.
Lifting and/or assisting patients during evaluations within crowded clinical environment.
Reaching by extending hand(s) or arm(s) in any direction.
Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
Communication skills using the spoken word.
Ability to see within normal parameters.
Ability to hear within normal range.
Ability to move about.
3 Research staff.
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 the 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.
Classified Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $39.310 - $54,060 annually (commensurate with experience) Employee group: Full Time Schedule: M-F; 8:30am - 5pm Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM DOM Pulmonary Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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