LEAD CLINICAL RESERACH COORDINATOR/PROJECT MANAGER

K2 Staffing LLC • Clermont, FL

9d

About The Position

K2 is pooling for the potential need for an experienced Lead Clinical Research Coordinator/Project Manager to support our clinic out of Winter Garden, FL. This position will manage clinical trial performance and ensure conduct is congruent to the philosophy and mission of K2 Medical Research. Promote good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and K2 Medical Research guidelines (SOPs) for the enrollment and maintenance of subjects in clinical trials, and by collecting, recording, and maintaining source and sponsor documentation.

Requirements

• 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.
• Strong working knowledge of GCP and FDA guidelines.
• Knowledge of medical terminology.

Nice To Haves

• Bilingual in Spanish/English highly desired.
• Bachelor's degree strongly preferred.
• Prior experience in a clinical environment preferred. Experience in clinical research and Parkinson's (neurodegenerative disease) is ideal.
• Phlebotomy, LPN, RN, or other medical licensure or certification preferred.
• BLS Healthcare Provider desired.
• 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.

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED