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.
• Prior experience in a clinical environment preferred. 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
...opportunity Delaware Norths Patina Group is hiring an Executive Sous Chef to join our team at Banners Kitchen and Tap in Boston,... ...reimbursement ~ Generous friends-and-family discounts at many of our hotels and resorts What will you do? Assist the Executive Chef...
...Center in Shrewsbury, MO is today the headquarters and curia (governing body) for the Archdiocese of St. Louis. Job Summary The Music Director is responsible for leading, coordinating, and overseeing all musical activities within an organization, production, or...
Landscaper Duties and Responsibilities Landscaper duties and responsibilities include: Use hand tools, such as shovels, rakes, pruning saws, saws, hedge or brush trimmers, or ax. Operate vehicles or powered equipment, such as mowers, tractors, twin-axle vehicles, snow...
...Job Description Top Job Located in Middlefield, OH Salary: $20.00/hour Our client in Middlefield, OH, is seeking a skilled CNC Lathe Operator to join their team. As an Operator, you will be responsible for operating a variety of machine tools to produce precision...
...This is a combination role that focuses on office management, bookkeeping, and administrative responsibilities year-round. The ideal... ...using Microsoft Office and Google Suite (Sheets primarily); QuickBooks experience preferred. Excellent attention to detail, organization...