Clinical/HC Research Associate
The Department of Epidemiology in the College of Public Health is seeking a 50-100% time Clinical/HC Research Associate to participate in the design, execution, and control of clinical research trials; coordinate the processing and analysis of trials data; coordinate clinical trial protocols and procedures; and develop new and/or revised research methodologies for MOST (Multicenter Osteoarthritis Study).
Research / Clinical ActivitiesoParticipate in the development of the general research goals and in the planning and implementation of the clinical trials.
oOversee operations of clinical research studies including the recruitment, coordination, and scheduling of subject participation and procedures per protocol requirements.
oOrganize clinic/study procedures, follow study participants, and manage collection of accurate data in a timely manner.
Keeping data and documentation secure and confidential.
oCoordinate services/referrals as appropriate with other departments participating in the clinical research as appropriate.
Protocol Development/Management and Study ResponsibilitiesoAssist in the design, development, and execution and administration of protocols and clinical studies.
oEnter patients in the protocol, ensuring that all prerequisites have been completed and are within the required parameters.
oAssist in judging validity to data and make recommendations.
Subject Recruitment and EnrollmentoAssist and/or direct others in obtaining patient consent to enter protocols and counsel patients and families regarding investigational therapy.
oCoordinate patient care needs and obtain follow up information from local physicians or laboratories or appropriate healthcare providers per established research protocols.
oAssist patients with problems related to their protocol therapy such as consultation when calling concerns related to:
returning for emergency evaluation in the case of side effects, assisting with emotional problems or other related areas.
Data Collection and MonitoringoCollect and manage data in clinical trials using a variety of data programs including REDCap data capture.
oMaintain records and services provided and work with individual protocol budgets.
oPerform complex statistical analysis of data and prepare data for computer analysis.
oUse evaluation data to revise and implement change.
oAssist in the preparation of research papers and manuscripts for publication and presentation at conferences and workshops, and in the writing of project reports, articles and other documents for submission to study sponsors.
Regulatory Guidelines and DocumentsoServe as a liaison to local physicians/hospitals and collaborating institutions to facilitate care of protocol patients when hospitalized at outside institutions.
oObtain documentation of the hospitalizations, as well as provide notification to the Principal Investigator, Study Sponsor and FDA as required per protocol.
Human Resources / Leadership oServe as a liaison to identify exact patient tests and procedures which are paid for by study sponsors, and to assist with questions related to billing for protocol treatment procedures.
oServe as a liaison to IRB committee.
Prepare and submit IRB information for approval.
oProvide administrative supervision.
oMentor new staff.
Requires:
Requires the academic knowledge, including advance study or demonstrated capacity for health or social science research that is generally associated with a Master's degree in Nursing or an equivalent combination of education and experience which consists of a Bachelor's Degree in Nursing (BSN) and professional nursing experience.
Current, valid Iowa Registered Nurse license.
Previous research protocol management experience including single and multi-institutional studies.
Experience with protocol therapy and medical research data management such as REDCap data capture.
Good written and verbal communication skills are required.
Familiarity with PC systems is required.
Valid US driving license and ability to meet the University of Iowa Fleet Safety Program driving standard is required.
Desires:
Supervisory experience is desired.
Knowledge of regulatory guidelines and procedures is desirable.
Orthopedic or rehabilitation experience is desirable.
Good Clinical Practices training is desirable.
Blood Borne Pathogen training is desirable.
Training and certification for shipping with dry ice is desirable.
Phlebotomy or venipuncture knowledge or experience desirable.
Fluency in speaking, reading, writing, and understanding the English and Spanish languages.
Position and Application Details:
This position is located at the Towncrest Clinic on the eastside of Iowa City.
To be considered for an interview, applicants must upload a resume and cover letter and mark them as a Relevant File to the submission.
Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended.
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification.
Up to 5 professional references will be requested at a later step in the recruitment process.
For questions, contact Michele Hogue at email protected .
Benefits Highlights:
Regular salaried position.
Located in Iowa City, Iowa.
Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans.
Recommended Skills Administration Billing Certified Nurse Practitioner Clinical Research Clinical Trials Communication Estimated Salary: $20 to $28 per hour based on qualifications.
Research / Clinical ActivitiesoParticipate in the development of the general research goals and in the planning and implementation of the clinical trials.
oOversee operations of clinical research studies including the recruitment, coordination, and scheduling of subject participation and procedures per protocol requirements.
oOrganize clinic/study procedures, follow study participants, and manage collection of accurate data in a timely manner.
Keeping data and documentation secure and confidential.
oCoordinate services/referrals as appropriate with other departments participating in the clinical research as appropriate.
Protocol Development/Management and Study ResponsibilitiesoAssist in the design, development, and execution and administration of protocols and clinical studies.
oEnter patients in the protocol, ensuring that all prerequisites have been completed and are within the required parameters.
oAssist in judging validity to data and make recommendations.
Subject Recruitment and EnrollmentoAssist and/or direct others in obtaining patient consent to enter protocols and counsel patients and families regarding investigational therapy.
oCoordinate patient care needs and obtain follow up information from local physicians or laboratories or appropriate healthcare providers per established research protocols.
oAssist patients with problems related to their protocol therapy such as consultation when calling concerns related to:
returning for emergency evaluation in the case of side effects, assisting with emotional problems or other related areas.
Data Collection and MonitoringoCollect and manage data in clinical trials using a variety of data programs including REDCap data capture.
oMaintain records and services provided and work with individual protocol budgets.
oPerform complex statistical analysis of data and prepare data for computer analysis.
oUse evaluation data to revise and implement change.
oAssist in the preparation of research papers and manuscripts for publication and presentation at conferences and workshops, and in the writing of project reports, articles and other documents for submission to study sponsors.
Regulatory Guidelines and DocumentsoServe as a liaison to local physicians/hospitals and collaborating institutions to facilitate care of protocol patients when hospitalized at outside institutions.
oObtain documentation of the hospitalizations, as well as provide notification to the Principal Investigator, Study Sponsor and FDA as required per protocol.
Human Resources / Leadership oServe as a liaison to identify exact patient tests and procedures which are paid for by study sponsors, and to assist with questions related to billing for protocol treatment procedures.
oServe as a liaison to IRB committee.
Prepare and submit IRB information for approval.
oProvide administrative supervision.
oMentor new staff.
Requires:
Requires the academic knowledge, including advance study or demonstrated capacity for health or social science research that is generally associated with a Master's degree in Nursing or an equivalent combination of education and experience which consists of a Bachelor's Degree in Nursing (BSN) and professional nursing experience.
Current, valid Iowa Registered Nurse license.
Previous research protocol management experience including single and multi-institutional studies.
Experience with protocol therapy and medical research data management such as REDCap data capture.
Good written and verbal communication skills are required.
Familiarity with PC systems is required.
Valid US driving license and ability to meet the University of Iowa Fleet Safety Program driving standard is required.
Desires:
Supervisory experience is desired.
Knowledge of regulatory guidelines and procedures is desirable.
Orthopedic or rehabilitation experience is desirable.
Good Clinical Practices training is desirable.
Blood Borne Pathogen training is desirable.
Training and certification for shipping with dry ice is desirable.
Phlebotomy or venipuncture knowledge or experience desirable.
Fluency in speaking, reading, writing, and understanding the English and Spanish languages.
Position and Application Details:
This position is located at the Towncrest Clinic on the eastside of Iowa City.
To be considered for an interview, applicants must upload a resume and cover letter and mark them as a Relevant File to the submission.
Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended.
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification.
Up to 5 professional references will be requested at a later step in the recruitment process.
For questions, contact Michele Hogue at email protected .
Benefits Highlights:
Regular salaried position.
Located in Iowa City, Iowa.
Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans.
Recommended Skills Administration Billing Certified Nurse Practitioner Clinical Research Clinical Trials Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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