Clinical Research Coordinator / Project Manager
- East Providence, RI
- Permanent
- Full-time
- Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator.
- Adhere strictly to the study protocol; obtain exemptions when necessary/appropriate.
- Communicate protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator.
- Articulate all pertinent issues to the Pl or document by email/letter or during meetings.
- Collect initial psychiatric and medical information by interviewing patients and by accessing other appropriate sources.
- Ensure a flow of communication including telephone conferences between patient, study staff, referral sources, Sponsor. and/or CRO, Monitor(s), Auditors and any marketing groups hired by the Sponsor.
- Utilize various psychiatric rating scales and maintaining interrater reliability with other clinicians at K2 Medical Research.
- Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, specimen packaging.
- Maintain timely K2 Medical Research source documentation as well as sponsor required information.
- Dispense and maintain accurate records of study medication.
- Educate patients and family regarding their particular study and clinical drug trials in general.
- Complete all monitor and sponsor queries in a timely manner.
- Provide appropriate community resource referrals to patients, caretakers, and family at conclusion of patient's participation in study.
- Outstanding verbal and written communication skills.
- Excellent interpersonal and customer services skills.
- Strong time management and organizational skills.
- In depth knowledge of industry regulations.
- Proven ability to and foster mentoring relationships.
- Ability to create momentum and foster organizational change.
- HS Diploma or GED Transcript required. Bachelor's degree strongly preferred.
- Two years of experience in a clinical environment. Experience in clinical research is ideal.
- LPN, RN, or another medical licensure or certification preferred.
- Strong working knowledge of GCP and FDA guidelines.
- Knowledge of medical terminology.
- BLS Healthcare Provider required.
- Applicants that do not meet 100% of the above qualifications but who have a combination of related education and applicable experience may be considered upon approval.
- Medical, Dental, Vision, Flexible Spending Accounts, Employer paid Long-Term disability and Life Insurance, Short Term Disability, Accident and Critical Illness Insurance, Voluntary Life and Long-Term Care Insurance, Legal Shield, Employee Assistance Program, and various discount programs.
- 401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested
- PTO of 16 days per year, 17 days after the first year of FT employment
- 9 paid Holidays
- K2 observes a four-day work week, Monday through Thursday, for full time employees. Fridays are non-working days unless required by business needs.