A.p.r.

3 - 6 Month Contract

Potential (Temp-to-Hire)

Fully Onsite

Monday - Friday

8:00 am - 5:00 pm

M-F 8am-5pm
FULLY On-site
Temp to hire
Qualifications & Requirements:

• Must have previous experience with COG
• Bachelor's degree in a scientific or healthcare field, or equivalent experience in Data entry, Research, Healthcare administration education in the protection of human research participants and Good Clinical Practices required.

Current clinical licensure and board certifications:

• SOCRA (preferred)
• ACRP (preferred within 4 years of hire)
• CITI training
• Human protections training
• IATA certification for shipping infectious substances and diagnostic specimens.
  

Ability to read and interpret:

• Research documents
• Clinical trial documents
• Operating and maintenance instructions
• Procedure manuals
• Strong written and verbal communication skills.
• Excellent interpersonal and relationship-building skills.
  

Ability to work effectively with:

• Physicians
• Physician offices
• Sponsors
• Hospital employees
• Strong analytical and problem-solving abilities.
  

Ability to work efficiently under:

• Tight deadlines
• High workloads
• Frequent interruptions
• Strong attention to detail and adherence to clinical trial requirements.
  

Clinical Research Coordinator – Key Responsibilities

• Prepare, submit, and monitor documentation for research programs.
• Ensure compliance with research regulations and protocols through audits.
• Advise caregivers on program design, treatment administration, and patient follow-up.
• Organize study files, including regulatory binders and source documentation.
• Maintain and update study files and records according to sponsor and institutional requirements.
• Review, edit, and update informed consent documents for clinical trials.
• Collaborate with the Principal Investigator (PI) to prepare IRB and regulatory submissions.
• Assist in reviewing eligibility criteria for participant enrollment.
• Coordinate enrollment of participants into Children's Oncology Group (COG) studies.
• Develop familiarity with COG protocols and specimen submission guidelines.
• Collect study data and ensure timely completion of Case Report Forms.
• Coordinate audits with the central COG office and maintain audit readiness.
• Perform additional duties as assigned.
  

Physical & Work Environment Requirements

• Work is mentally and visually demanding for more than 90% of the work time.
• Requires considerable standing and walking.
• Requires lifting light objects (up to approximately 20 pounds).
• May involve assisting with lifting or moving patients.
• Requires maintaining potentially fatiguing positions and performing repetitive physical movements.
  

Clinical Research Coordinator (CRC):

• For all new Trials, confirm if DTL must be created and if slide deck training is required
• Take primary responsibility for early specimen/x-ray/lab submission for RAPID EARLY Review
• Obtain parental consent for APEC14B1 (parental DNA and part B if needed)
• Maintain BMH compliance Spreadsheets with updates (quarterly, on SharePoint)
• Track patients on study and in follow-up
• Maintain Outlook Calendar for upcoming time points/appointments
• Complete all CRFs for Baseline, Reporting Period and Follow-up folders for all patients.
• Monitor SADD list weekly
• Attend daily check-in and chemotherapy rounds
• Collect all patient documents for diagnosis and treatment courses
• Prepare AE flow sheets for each therapeutic trial
• Attend CRCWM Pediatric Protocol reviews first Thursday every month at 0700
• Know investigational agents and how to get them (drug ordering)
• Prepare charts for AUDIT, attend COG meetings
  

Clinical Research Coordinator (CRC) and Clinical Research Assistant (CRA):

• CITI training/Human Protections training
• Dangerous Goods training
• Patient Registration
• Confirming eligibility/ Fast Facts reviewed
• Review all consents for correct signatures/initials on day signed
• Attend weekly COG working group meetings
• Attend Teams meetings with Helen DeVos Children’s Hospital every 2 weeks

Maintain active account access and training for:

• iMedidata/Rave
• COG/eRDS
• CTSU/OPEN
• Redcap*
• TRIAD*
• CRCWM

AlphaProTemps is specialized in providing "best-in-class" professional staff augmentation services. These recruiting directives include temporary labor, contract sourcing, professional & technical niches, vendor-on-site, and managed service programs.