Clinical Research Coordinator / Project Manager
Job DescriptionJob Description
At K2 Medical Research, a privately-owned clinical research facility with Head Quarters in the Central Florida area, we specialize in conducting multiphasic clinical trials that promote the development of innovative and effective medical treatments while maintaining the safety and privacy of our participants. We are committed to fighting the diseases that plague our loved ones and ourselves. By harnessing the power of advanced clinical research and connecting our patients with the treatments of tomorrow, we can improve the health of our local communities, and by extent, the population of our world.
K2 Medical Research is seeking a Clinical Research Coordinator / Project Manager to support our East Providence, RI clinic. We're looking for individuals who can manage clinical trials, ensure studies follow federal regulations and K2's guidelines (SOPs), and handle all necessary documentation for subject enrollment and maintenance.
Primary Responsibilities:
- 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.
Knowledge, Skills, and Abilities:
- 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.
Qualifications:
- HS Diploma or GED Transcript required. Bachelor's degree strongly .
- Two years of experience in a clinical environment. Experience in clinical research is ideal.
- LPN, RN, or another medical licensure or certification .
- 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.
Benefits:
We value our employees and their professional and personal needs, and support these through our benefit offerings:
- Medical, Dental, Vision, Flexible Spending Accounts, Employer paid Long-Term and Life Insurance, Short Term , 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.
Join the K2 Family: Where Compassion and Connection Lead the Way!
At K2 Med, people come first and we're seeking warm, wonderful humans who effortlessly click with everyone, from our incredible patients to brilliant physicians and dedicated research staff. We thrive on empathy, a patient-first approach, and absolutely zero big egos (unless it's an ego about being extra kind, then we'll allow it!). We believe a supportive, caring experience is paramount for our patients, and that starts with you.
We celebrate what makes you uniquely you! Your , , , marital status, , , or even your favorite snack (though we're partial to good research snacks) don't define your talent or fit here. If you need a little extra support or accommodation due to a , no sweat! Just reach out to our friendly team at HR@k2med.com, and we'll ensure you have everything you need to shine.