OBOT Research CoordinatorWorking under the direction of the Site PI, the Research Coordinator will serve as the main site contact for the study. They will also complete all other essential duties as detailed below.Essential Job Functions
- Serves as the main site contact for the study.
- Performs activities necessary to recruit, screen, and randomize sufficient numbers of study participants.
- Conducts study visits, collects study data (including urine sample collection), completes visit progress notes, maintains accurate data on forms (including eCRFs), and responds to all data queries.
- Develops local Standard Operating Procedures (SOPs) in order to implement the protocol and procedures at the local site.
- Prepares and disseminates administrative reports as needed, including reports of safety events, protocol deviations, and study progress, and assists with local and/or centralized IRB submissions, as needed.
- Maintains on-site regulatory records.
- Completes regular inventory of study-provided medications and supplies and reports to the CCC. Maintains adequate supply inventory for materials provided by the site.
- Oversees storage and accountability of study medications, as designated by the Site PI. In the absence of a study pharmacist or other designee, such as Project Manager, may be responsible for study medication management (receiving and documenting shipments with appropriate licensure for storing and receiving DEA-regulated medication; maintenance of temperature logs; storage of study medication per local and federal regulations; etc.).
- Is one of the two designated staff for Veeva Vault and may be one of two designated International Air Transport Association (IATA) trained staff members for packing and shipping exempt human specimens.
- Assists in coordinating both the CCC and local Node Quality Assurance monitoring visits and ensures that all findings are addressed in a timely manner.
- Participants in conference calls with the Lead Team.
Minimum Qualifications - Previous work in clinical trials preferred but not required
- Ability to work in a team environment and independently
- Strong organizational and communication skills
- Flexibility to adapt to changing protocols
- Familiarity with GCP and HSP protocols preferred but not required
- Experience in data collection
- Experience in recruitment/marketing a plus
- Satisfactory references from employers and/or professional peers.
- Satisfactory criminal background check.
- Satisfactory drug screen.
Benefits:- Competitive salary
- Comprehensive benefits package including medical, dental, vision and 401(K)
- Generous paid time off accrual
- Excellent growth and development opportunities
- Satisfying and rewarding work striving to overcome the opioid epidemic
Here is what you can expect from us:AppleGate Recovery, aprogressive substance abuse treatment organization, is committed to the highest quality of patient care in a comfortable outpatient clinic setting.Our ultimate goal is to address the physical, emotional, and mental aspects of opioid use disorder to help each of our patients achieve long-term recovery and an improved quality of life.
AppleGate Recoveryis committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, natural origin, ethnicity, religion, gender, pregnancy, marital status, sexual orientation, citizenship, genetic disposition
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