Lead Project Manager

K2 Staffing LLC • Maitland, FL

7h • Onsite

About The Position

K2 is seeking an experienced Lead Clinical Research Coordinator/Project Manager to support our clinic out of Orlando (Maitland), FL. This position will supervise a team of Project Managers; assist the Site Director with day-to-day operations; and provide leadership and support to clinical staff to ensure high quality/high volume of work, efficient productivity, and maintain effective + positive working relationships with patients, sponsors, physicians, and employees.

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.
• At least two (2) full years of Clinical Research Coordinator or Project Manager experience 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.
• CCRC certification preferred.
• BLS Healthcare Provider desired.

Responsibilities

• Train new and current Project Managers and Clinical Research Assistants to ensure effective coordination of training activities in the clinical trials processes
• 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: Manager
• Education Level: High school or GED
• Number of Employees: 1-10 employees