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Study Coordinator - Full-time / Part-time
•30 days ago
| Hours | Part-time, Full-time |
|---|---|
| Location | Scottsdale Scottsdale, Arizona |
About this job
REPORTS TO:Dr. Suzanne Sisley, Site Principal Investigator
EMPLOYMENT DATES:
Ready to begin September 2015 and work on an annual contract basis for duration of the study. Study is expected to last from September 2015-September 2018.
HOURS:
Hours for the position are full time for at least 24 months of work.
SUMMARY:
The individual in this position is responsible for the professional execution of clinical research activities under the direction of the Site Principal Investigator.
RESPONSIBILITIES:
* Collaborate within a team throughout the clinic and the Sponsor in order to successfully conduct the clinical trial.
* Provide support and tracking of fiscal study management, preparing invoices for services and payment.
* Oversee study operations, filing of essential documents, regulatory documentation and keeping tracking logs up to date.
* Coordinate all aspects of subject participation associated with trial execution including subject recruitment, appointment making, screening, enrollment, consent, lab work, and drug distribution providing updates to team members as needed.
* Perform phlebotomy, sample processing, storage and shipping.
* Participate in regular team meetings.
* Ensure general inquiries from current and prospective participants and others are appropriately managed.
* Maintain Source Records and complete electronic Case Report Form with input from the Investigator.
* Provide on site support in cases of anomalies or emergencies and ensure timely completion of safety reporting forms.
* Provide general support for a successful completion of the study.
* Participate in managing drug dispensation, return and accountability.
QUALIFICATIONS:
* Bachelor's Degree with at least 5 years of clinical research experience.
* Interest in gaining experience working on a FDA approved clinical trial following ICH/GCP.
* Excellent follow through and time management.
* Strong communication skills, both verbal and written.
* Computer-literate, Proficient in MS Office applications.
* Proficient with electronic or remote data capture.
* High attention to detail.
* Able to mulit-task with strong problem solving skills.
* Ability to prioritize daily workload and follow through productively.
* Comfortable working independently and as part of a team.
* Knowledge of ICH/GCP guidelines and FDA CFR regulations as they apply to clinical research.
* Living in the Scottsdale area, AZ
* Trained in shipping of specimens (IATA).
* Able to pass a DEA background check with no record of felony drug charges.
Payroll taxes will be paid by the employer and reimbursement for health care benefits will be provided.
ABOUT US:
Investigators are conducting a triple-blind, placebo-controlled study investigating the use of marijuana in treating the symptoms veterans with Posttraumatic Stress Disorder (PTSD). Marijuana is a Schedule 1 controlled substance. This study is sponsored by the Colorado Department of Public Health and Environment and MAPS, a non-profit, membership-based research and educational organization and is being conducted as a pharmaceutical trial under the jurisdiction of the US FDA. MAPS' mission is 1) to treat conditions for which traditional medicines provide limited relief-such as posttraumatic stress disorder (PTSD), pain, drug dependence, and anxiety and depression associated with end-of-life issues-by developing psychedelics and marijuana into prescription medicines; 2) to cure people by building a network of clinics where treatments can be provided; and 3) to educate the public honestly about the risks and benefits of these drugs.
EMPLOYMENT DATES:
Ready to begin September 2015 and work on an annual contract basis for duration of the study. Study is expected to last from September 2015-September 2018.
HOURS:
Hours for the position are full time for at least 24 months of work.
SUMMARY:
The individual in this position is responsible for the professional execution of clinical research activities under the direction of the Site Principal Investigator.
RESPONSIBILITIES:
* Collaborate within a team throughout the clinic and the Sponsor in order to successfully conduct the clinical trial.
* Provide support and tracking of fiscal study management, preparing invoices for services and payment.
* Oversee study operations, filing of essential documents, regulatory documentation and keeping tracking logs up to date.
* Coordinate all aspects of subject participation associated with trial execution including subject recruitment, appointment making, screening, enrollment, consent, lab work, and drug distribution providing updates to team members as needed.
* Perform phlebotomy, sample processing, storage and shipping.
* Participate in regular team meetings.
* Ensure general inquiries from current and prospective participants and others are appropriately managed.
* Maintain Source Records and complete electronic Case Report Form with input from the Investigator.
* Provide on site support in cases of anomalies or emergencies and ensure timely completion of safety reporting forms.
* Provide general support for a successful completion of the study.
* Participate in managing drug dispensation, return and accountability.
QUALIFICATIONS:
* Bachelor's Degree with at least 5 years of clinical research experience.
* Interest in gaining experience working on a FDA approved clinical trial following ICH/GCP.
* Excellent follow through and time management.
* Strong communication skills, both verbal and written.
* Computer-literate, Proficient in MS Office applications.
* Proficient with electronic or remote data capture.
* High attention to detail.
* Able to mulit-task with strong problem solving skills.
* Ability to prioritize daily workload and follow through productively.
* Comfortable working independently and as part of a team.
* Knowledge of ICH/GCP guidelines and FDA CFR regulations as they apply to clinical research.
* Living in the Scottsdale area, AZ
* Trained in shipping of specimens (IATA).
* Able to pass a DEA background check with no record of felony drug charges.
Payroll taxes will be paid by the employer and reimbursement for health care benefits will be provided.
ABOUT US:
Investigators are conducting a triple-blind, placebo-controlled study investigating the use of marijuana in treating the symptoms veterans with Posttraumatic Stress Disorder (PTSD). Marijuana is a Schedule 1 controlled substance. This study is sponsored by the Colorado Department of Public Health and Environment and MAPS, a non-profit, membership-based research and educational organization and is being conducted as a pharmaceutical trial under the jurisdiction of the US FDA. MAPS' mission is 1) to treat conditions for which traditional medicines provide limited relief-such as posttraumatic stress disorder (PTSD), pain, drug dependence, and anxiety and depression associated with end-of-life issues-by developing psychedelics and marijuana into prescription medicines; 2) to cure people by building a network of clinics where treatments can be provided; and 3) to educate the public honestly about the risks and benefits of these drugs.
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