Summary

The role of the Clinical Study Coordinator is to ensure patient safety and wellbeing. The Clinical Study Coordinator will coordinate and perform study visits under the guidance and supervision of the principal investigator. This is an office-based position, working in the same location as the principal investigator or in the designated clinic.

To be successful in this role, the Clinical Study Coordinator should be able to perform critical patient evaluations, in addition to recognizing logistical problems and initiating appropriate solutions. Ideal candidates will be patient-focused, detail-oriented, have the ability to multitask, and be able to collaborate with various role players. The Clinical Study Coordinator must be able to work independently, be a team player, and proactively problem solve.

Qualifications

• Bachelors Degree with related clinical experience
• Experience working on clinical trials for a minimum of 2 years
• Knowledge of FDA regulations and GCP
• Accuracy, attention to detail, and ability to set priorities and meet deadlines
• Basic Computer Skills required: Microsoft Office Suite, including Word PowerPoint, Excel
• Other Skills required:
  • Excellent bedside manner and patient-centric focus
  • Excellent time management and social skills
  • Highly motivated with a phenomenal eye for detail

Duties and Responsibilities

Develop management systems and prepare for study initiation:

1. Assess study feasibility in terms of study's impact on-site resources, labor cost, cost by procedure, the potential for problems (such as serious AEs, noncompliance, the willingness of subjects to participate, protocol deviations, etc.)
2. Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility
3. Review with the Principal Investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol
4. Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity
5. Develop draft protocol follow-up worksheets and then review the worksheets for accuracy and clarity
6. Develop a mechanism for subject recruitment and ongoing communications with primary care physicians and nursing staff, as appropriate.

Screen and enroll study subjects:

1. Review the study design and inclusion/exclusion criteria with the subject’s primary physician
2. Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility
3. Review the protocol, informed consent form and follow-up procedures with potential study subjects
4. Ensure that the current approved informed consent is signed before subjects are screened and enrolled
5. Ensure that the randomization procedure is followed as per protocol guidelines
6. Document protocol exemptions and deviations.

Manage study-related activities, subject compliance and documentation:

1. Ensure adherence to protocol requirements
2. Schedule subjects for follow-up visits
3. Assist investigators in assessment of subject response to therapy
4. Review laboratory data, inform investigator of abnormal values and document
5. Report to primary care provider as appropriate
6. Assess and document subject compliance with medications and visits
7. Communicate with pharmacy staff to assure timely and accurate study drug distribution
8. Manage administration of investigational therapy
9. Maintain dispensing logs (if allowed)
10. Maintain copies of any documentation for dispensing of investigational products and/or study-related supplies
11. Oversee specimen collection, storage and shipment
12. Attend study-related meetings as appropriate
13. Communicate regularly with the principal investigator, monitor (and others responsible for conduct of the research) about study-related issues.

Record data and study documentation:

1. Record data as directed using the appropriate media or platform
2. Follow procedures for access and security for electronic data entry
3. Review keyed data for accuracy, as needed
4. Send data to the data collection center on a timely basis
5. Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports
6. Correct and edit data as directed and as appropriate.

Monitor and report adverse events:

1. Assess, document and record all AEs as outlined in the protocol
2. Report serious AEs o the Principal Investigator, Sponsor and IRB (and others as required by funding source or as outlined in the protocol).
3. Regulatory documentation:
4. Know and understand all regulatory requirements associated with the conduct of the study assigned
5. Maintain files and documents as regulations dictate
6. Prepare and submit initial applications to central and local committees (IRBs, biosafety, radiology, etc.), prepare and submit reports, as required
7. Ensure that all required documentation is complete and appropriately filed.

Management of site activities during audits and inspections:

1. Prepare for quality assurance audits and regulatory inspections, as needed
2. Act as contact person before, during and after audits and inspections
3. Provide all required documentation to auditors
4. Make all appropriate corrections as requested by auditors
5. Coordinate site response to audit/inspection findings.

Competencies

• Diversity – Willingness to follow Equal Employment Opportunity (EEO) policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.
• Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
• Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
• Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals.
• Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
• Cost Consciousness - Works within approved budget; Develops and implements cost-saving measures; Contributes to profits and revenue; Conserves organizational resources.
• Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
• Design - Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
• Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
• Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
• Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
• Judgement - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
• Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem-solving situations; Uses reason even when dealing with emotional topics.
• Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
• Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
• Visionary Leadership - Displays passion and optimism; Inspires respect and trust; Mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates.
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.

WORK ENVIRONMENT

• This is an office-based position with a clinical unit.