K2 STAFFING LLC
Clinical Research Coordinator / Project Manager at K2 STAFFING LLC Nashville, TN
K2 STAFFING LLC, Nashville, Tennessee, United States, 37247
Clinical Research Coordinator / Project Manager job at K2 STAFFING LLC. Nashville, TN.
Clinical Research Coordinator 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 Clincial Research Coordinator 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.
Two years of experience in a clinical environment. 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.
We value our employees and their professional and personal needs, and support these through our benefit offerings:
Insurance
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.
Retirement
401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested
PTO / Holidays
PTO of 16 days per year, 17 days after the first year of FT employment
9 paid Holidays
Work-Life Balance
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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Clinical Research Coordinator 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 Clincial Research Coordinator 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.
Two years of experience in a clinical environment. 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.
We value our employees and their professional and personal needs, and support these through our benefit offerings:
Insurance
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.
Retirement
401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested
PTO / Holidays
PTO of 16 days per year, 17 days after the first year of FT employment
9 paid Holidays
Work-Life Balance
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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