Clinical Research Coordinator/Project Manager

4 weeks ago

Orlando, United States K2 STAFFING LLC Full time
Job DescriptionJob Description

At K2 Medical Research, a privately-owned clinical research facility in the greater Orlando and 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.

Description:

The Project Manager will manage clinical trial performance and ensures 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.

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 preferred.

• Prior experience in a clinical environment required. Experience in clinical research is ideal.

• LPN, RN, or other medical licensure or certification preferred.

• Strong working knowledge of GCP and FDA guidelines

• Knowledge of medical terminology

• BLS Healthcare Provider required

• Bilingual Preferred

• 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


At K2, 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 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.



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