We are seeking a Senior Research Program Coordinator II who will oversee the administrative and scientific implementation of clinical trials and investigator-initiated research (IR) protocols for the Greenberg Center for Skeletal Dysplasia's in the Department of Genetic Medicine. Candidate will utilize a thorough knowledge of concepts and theories in research studies and associated protocols for the design, implementation, oversight, and data analysis of clinical trials.
Collaborate with faculty and various internal staff members on development, implementation and management of various research studies including pharmaceutical sponsored research and investigator-initiated research. Daily responsibilities will involve all aspects of clinical trial and IR protocol execution. Emphasis on ability to work independently to implement clinical trials and IR protocols in collaboration with PI.
Specific Duties & Responsibilities:
Assist PI in managing a $1M+ clinical research study including site initiation, ongoing site visits, recruitment, training, education, and data management.
Development, testing and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data. This includes development of SOPs for subject study visits. Assist with protocol development of sub-studies.
Prepare institutional review board application from industry protocol or IR-developed protocol.
Budget preparation for clinical trials in conjunction with the PI, sponsor, and ORA. Tracking all clinical trial expenses over study execution and reporting these data to the Greenberg Center Program Administrator for quarterly invoicing.
Coordinate serious adverse events reporting, annual renewals, and regulatory notifications with clinicians and investigators to ensure prompt reporting to JHMIRB and study sponsors.
Participate as a member of collaborative group study team in study design, analysis of data, involved in discussions and recommendations for next steps.
Facilitate communication among ORA, sponsor, and PI for contract negotiations.
Establish local study activity scheduling and payment.
Recruitment of study subjects, in conjunction with PI, collaborators. Scheduling of all patients in GCRC Online for all clinical research activities. Obtain informed consent under supervision of PI. Obtaining research meds from research pharmacy for study patients. Communicate with study participants before, during and after research visits.
Oversee data collection at our Johns Hopkins site for the multi-center Global BioMarin Trial 302, the multi-center Global Alexion Trial 501; and. the multi-center National Clarity /Redcap 2 Study.
Responsible for the accurate collection and record maintenance of research data, and IRB documents. Accurate data entry into the CRMS database, the BioMarin Imedidata Global database for 302, the Rave HPP Registry for the Alexion 501 study, the Redcap Clarity database, Respond to all inquiries from the CRO's in the database. Organize, review, and edit raw data with PI to make appropriate data revisions.
Attend and coordinate site visits. Prepare required documents and materials for site visits. Follow up and complete all site visit recommendations.
Maintain ongoing invoicing with study sponsor and Program Administrator.
ICTR/CRU application and training ICTR/CRU personnel for study.
Biologic sample mailing.
Present data for internal meetings and study monitors. Assist with the presentation preparation of projects/data at medical meetings.
Maintains good working knowledge of all assigned protocols, maintains regulatory documentation for each assigned protocol, reviews data accuracy with PI regularly and updates on overall progress. Abstract and index information based on knowledge of subject matter.
Perform self-audits for assigned studies and audit multiple personnel data entries for the BioMarin 302 study and collaborator entries for the Redcap clarity study.
Other duties as assigned.
Minimum Qualifications (Mandatory):
Bachelor's Degree in related discipline.
Five years related experience. Additional education can substitute for experience, to the extent permitted by the JHU equivalency formula.*
* JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience. 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.
Clinical research experience, including IRB application and maintenance process.
Special Knowledge, Skills & Abilities:
Ability to work in MS Excel, MS Access, and MS Word required.
Attention to detail, as well as the ability to work independently.
Reaching by extending hand(s) or arm(s) in any direction.
Finger dexterity to manipulate objects with fingers rather than with whole hand or arm.
Communication skills using the spoken word.
Ability to see and hear within normal parameters; lift, carry, move supplies, computers, glassware, etc.
Ability to move about workspace.
Classified Title: Sr. Research Program Coordinator II Role/Level/Range: ACRP/04/MC Starting Salary Range: $45,650 - $62,850 annually (commensurate with experience) Employee group: Full Time Schedule: Mon- Fri 8:30 am - 5 pm Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM Genetics Greenberg Ctr Skel Dysplasi Personnel area: School of Medicine
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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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