Clinical Research Coordinator/Project Manager Job at K2 Medical Research, The Villages, FL

VjZ1MGo1VkJVMUg5L21kbTZ4ci95OXdtS1E9PQ==
  • K2 Medical Research
  • The Villages, FL

Job Description

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.
  • 2 years experience in clinical research is preferred.
  • 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

Job Tags

Similar Jobs

Eliassen Group

User Acceptance Test Analyst Job at Eliassen Group

 ...Description: Our client is looking for user acceptance testers with at least five years of experience to support the implementation of...  ...business details and requirements to create, execute and document test scenarios and cases, identify defects and build a plan for re-... 

Toshiba America Energy Systems

CNC Machinist (2nd SHIFT) Job at Toshiba America Energy Systems

 ...generation needs in the Americas, including thermal, hydro and nuclear power plants. Position Summary We are seeking a 2nd shift CNC Machinist to work out of the West Allis, WI facility. The CNC machinist sets up and operates CNC machines or machining centers to... 

Grande Cosmetics

Social Media Manager Job at Grande Cosmetics

 ...this role. Please do not reach out. Were looking to add a social media manager to our team. This is an incredible opportunity to join a well...  ...5%, competitive PPO, paid parental & maternity leave, hybrid work schedule, growth & development opportunities & more.... 

YES Network

Senior Analyst, Growth Marketing Job at YES Network

Senior Analyst, Growth Marketing YES Network for the Gotham Advanced Media and Entertainment (G.A.M.E) Gotham Advanced Media and Entertainment (G.A.M.E.), a joint venture of Yankees Entertainment and Sports Network (YES) and MSG Networks (MSGN), is actively...

Flowers Foods & Subsidiaries

Maintenance Supervisor Job at Flowers Foods & Subsidiaries

 ...vary depending on your work location and your participation in a collective bargaining unit. Bringing Home the Dough: Maintenance Supervisor's plan, assign, supervise, and directs activities of hourly team members. Rising to the Challenge: Position...